{"id":19145,"date":"2026-06-17T17:10:02","date_gmt":"2026-06-17T10:10:02","guid":{"rendered":"https:\/\/www.tibdglobal.com\/product\/syrup-stability\/"},"modified":"2026-10-01T15:25:20","modified_gmt":"2026-10-01T08:25:20","slug":"syrup-stability","status":"publish","type":"product","link":"https:\/\/www.tibdglobal.com\/en\/product\/syrup-stability\/","title":{"rendered":"Herbal Powder and Syrup Stability Testing Service"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_section][vc_row][vc_column][vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"11:1-11:701;275-975\">Herbal powders and syrups are two dosage forms regulated under the Thai Herbal Product Act B.E. 2562 (2019) that are particularly sensitive to the high temperature and humidity of ASEAN Zone IVb. Herbal Powder products prepared by spray drying, freeze drying, or direct milling of dried herbs present challenges including moisture absorption, Caking, Hygroscopicity, Maillard reaction, and microbial growth. Herbal Syrup products formulated with sugar, honey, or polyols as the main vehicle present challenges including microbial growth, sedimentation of suspended herb particles, glycoside hydrolysis, pH change, and Brix drop from sucrose inversion under acidic conditions and elevated temperature.<\/p>\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"13:1-13:677;977-1653\">TIBD&#8217;s service is designed specifically for Herbal Powder and Syrup dosage forms, covering Moisture Content, Water Activity, Particle Size, Hygroscopicity by Dynamic Vapor Sorption (DVS) Sorption Isotherm, pH, Brix by Refractometer, Viscosity, Sedimentation Rate, Microbiology including Total Microbial Count, Yeast and Mold Count, and Preservative Efficacy Test (PET) per ISO 11930, Marker Compound Assay by High Performance Liquid Chromatography (HPLC), TLC Fingerprinting, and GC-MS for Volatile Compounds under ASEAN Zone IVb conditions per ICH Q1A(R2), in partnership with VISBIO as an Independent Quality Assurance Verifier (IQAV) using Validated Methods per ICH Q2(R1).<\/p>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b8101dc7db\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b8101dc7db wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"herbal_powder_and_syrup_product_types_in_the_thai_and_asean_market\"><\/span>Herbal Powder and Syrup Product Types in the Thai and ASEAN Market<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"17:1-17:129;1728-1856\">Nine product types covering the main Herbal Powder and Syrup formats are commercially produced in Thailand and the ASEAN region.<\/p>\r\n\r\n<ul>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"19:1-19:373;1858-2230\">Spray-Dried Herbal Extract Powder is produced by atomizing a liquid herbal extract into a heated drying chamber where the droplets evaporate rapidly to form hollow microspheres. Spray-dried powders have high surface area and are highly hygroscopic; they require strict Moisture Content and Water Activity control and appropriate packaging to prevent Caking during storage.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"21:1-21:348;2232-2579\">Freeze-Dried Herbal Extract Powder (Lyophilized Powder) is produced at low temperature and pressure, preserving thermolabile Marker Compounds such as Asiaticoside and enzymes better than spray drying. Freeze-dried powders are very porous and highly hygroscopic. They are typically filled into sachets or capsules rather than stored as bulk powder.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"23:1-23:354;2581-2934\">Whole Herb Powder is produced by milling dried herb material to a defined particle size range. This format contains the full herb matrix including fiber, starch, and cell wall material. Whole Herb Powders for direct consumption or sachet use require Moisture Content control and Aflatoxin monitoring, particularly for ginger, turmeric, and black pepper.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"25:1-25:368;2936-3303\">Instant Herbal Powder (Soluble Sachet) is produced by blending spray-dried extract with soluble carriers such as Maltodextrin, Inulin, or Sucrose and packaging in foil-laminate sachets. Stability challenges include moisture absorption causing Caking, Maillard browning between reducing sugars and amino acids, and aroma loss from volatile Marker Compound degradation.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"27:1-27:303;3305-3607\">Traditional Herbal Syrup is produced by decocting dried herbs in water and concentrating with sugar or honey to achieve a Brix of 50 to 70\u00b0Bx. This format is widely used in Thai traditional medicine for respiratory, digestive, and tonic preparations and is registered under the Thai National Formulary.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"29:1-29:311;3609-3919\">Contemporary Herbal Syrup uses a standardized herbal extract in a formulated syrup base with Xanthan Gum or Carbomer as suspending agent, Sodium Benzoate or Potassium Sorbate as preservative, and Citric Acid or Lactic Acid for pH adjustment. This format allows quantitative Marker Compound claims on the label.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"31:1-31:308;3921-4228\">Honey-Based Herbal Syrup incorporates honey as both the main vehicle and natural preservative. The stability of honey-based syrups depends on the Water Activity of the honey, which must be below 0.6 to prevent yeast fermentation. Monitoring Brix and Water Activity is particularly important for this format.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"33:1-33:373;4230-4602\">Pediatric Herbal Syrup is formulated for children with a lower sugar concentration, pleasant taste masking, and age-appropriate dosing per unit volume. The microbial stability of pediatric syrups is critical because of the repeated opening and closing of the bottle during use; In-use Stability testing is required to confirm microbial safety throughout the in-use period.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"35:1-35:413;4604-5016\">Herbal Syrup for Cough, Respiratory, and Tonic Applications represents the highest-volume category of herbal syrup products in Thailand, with registered products based on Andrographis paniculata, Clinacanthus nutans, Morinda citrifolia, Zingiber officinale, and Thai traditional formula combinations. These products must comply with THP 2021 monograph specifications and Thai FDA Herbal Product Act requirements.<\/li>\r\n<\/ul>\r\n[\/vc_column_text][vc_single_image image=&#8221;19004&#8243; img_size=&#8221;full&#8221; parallax_scroll=&#8221;no&#8221; woodmart_inline=&#8221;no&#8221;][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b811c179f4\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b811c179f4 wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"specific_stability_challenges_in_tropical_climates\"><\/span>Specific Stability Challenges in Tropical Climates<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"39:1-39:147;5075-5221\">Eight stability challenges specific to Herbal Powders and Syrups must be addressed in a stability protocol designed for ASEAN Zone IVb conditions.<\/p>\r\n\r\n<ol>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"41:1-41:612;5223-5834\">The first challenge is Hygroscopicity and Caking in Herbal Powder products. Spray-dried and freeze-dried herbal powders absorb moisture rapidly from the ambient environment, increasing Water Activity above the 0.6 safety threshold and causing individual powder particles to stick together into hardened lumps (Caking). Hygroscopicity is measured quantitatively by Dynamic Vapor Sorption (DVS) Sorption Isotherm, which maps the moisture absorption behavior of the powder across a range of relative humidity values. This data informs the selection of packaging material and desiccant requirements for the product.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"43:1-43:519;5836-6354\">The second challenge is Maillard reaction in powder products containing both reducing sugars and amino acids. The Maillard reaction is a non-enzymatic browning reaction between carbonyl groups from reducing sugars (Glucose, Fructose, Maltose) and free Amino Groups from amino acids or proteins in the herbal extract, producing brown-colored melanoidin compounds and characteristic aroma changes. Maillard browning is accelerated by elevated temperature and moisture. Color change is assessed by CIE L<em>a<\/em>b* Colorimetry.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"45:1-45:375;6356-6730\">The third challenge is aroma and flavor change in Herbal Powders and Syrups from degradation of Volatile Compounds. Essential oil constituents including Terpenes, Phenylpropanoids, and Sesquiterpenes evaporate or degrade under elevated temperature storage, causing loss of characteristic aroma and taste. Volatile Compound stability is monitored by GC-MS headspace analysis.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"47:1-47:410;6732-7141\">The fourth challenge is microbial growth in Herbal Syrups, particularly in pediatric and honey-based formulations. Syrups with Brix below 50\u00b0Bx or Water Activity above 0.6 are susceptible to yeast and mold contamination during shelf life. Preservative Efficacy Test (PET) per ISO 11930 confirms that the preservative system maintains microbial control throughout the product life, including the In-use period.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"49:1-49:375;7143-7517\">The fifth challenge is Sedimentation and phase separation of suspended herb particles in Herbal Syrups. Suspended particulates settle over time under gravitational force, producing a sediment layer that may be difficult to re-suspend and that causes non-uniform dosing. Sedimentation Rate is assessed by visual observation and by Turbidimeter measurement at each Pull Point.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"51:1-51:403;7519-7921\">The sixth challenge is glycoside hydrolysis in acidic Herbal Syrups. The glycosidic bond of herbal Marker Compounds such as Andrographoside, Baicalin, and Glycyrrhizin is cleaved by acid hydrolysis under the low pH and elevated temperature conditions of tropical storage, releasing the aglycone. Stability Indicating HPLC methods must resolve the parent glycoside from its aglycone degradation product.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"53:1-53:444;7923-8366\">The seventh challenge is pH change and sucrose inversion in sugar-based Herbal Syrups. Sucrose undergoes acid-catalyzed hydrolysis to Glucose and Fructose (inversion) under acidic conditions and elevated temperature, causing a decrease in Brix and a change in sweetness profile. A pH drop of more than 0.5 units or a Brix drop of more than 5% from the initial value is considered significant and indicates formulation or packaging instability.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"55:1-55:365;8368-8732\">The eighth challenge is Marker Compound degradation. The HPLC assay must confirm that the Marker Compound content is maintained throughout the declared shelf life for both powder and syrup dosage forms. Degradation rates in liquid (syrup) formulations are generally faster than in solid dosage forms due to greater molecular mobility and direct contact with water.<\/li>\r\n<\/ol>\r\n[\/vc_column_text][vc_single_image image=&#8221;18999&#8243; img_size=&#8221;full&#8221; parallax_scroll=&#8221;no&#8221; woodmart_inline=&#8221;no&#8221;][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b8138db3e6\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b8138db3e6 wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"testing_parameters_for_herbal_powder\"><\/span>Testing Parameters for Herbal Powder<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"59:1-59:268;8777-9044\">Moisture Content is measured by Karl Fischer Titration or Loss on Drying. The acceptance criterion for spray-dried herbal extract powders is 3 to 5%. Moisture Content exceeding 5% is associated with Caking, accelerated Maillard browning, and increased microbial risk.<\/p>\r\n\r\n<ul>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"61:1-61:274;9046-9319\">Water Activity (aw) is measured by Water Activity Meter. The acceptance criterion is Not More Than 0.6 to prevent microbial growth. Monitoring Water Activity is particularly important for hygroscopic powders stored in packaging with inadequate moisture barrier performance.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"63:1-63:294;9321-9614\">Particle Size Distribution is measured by Laser Diffraction or Sieve Analysis. Caking causes a shift in the Particle Size Distribution toward larger agglomerate sizes. Monitoring D50 and D90 values at each Pull Point detects the onset of Caking before it becomes apparent by visual inspection.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"65:1-65:353;9616-9968\">Hygroscopicity is assessed by Dynamic Vapor Sorption (DVS) Sorption Isotherm analysis, which measures moisture uptake as a function of relative humidity. The DVS data is used to calculate the Critical Relative Humidity (CRH) above which the powder absorbs moisture rapidly, informing the specification for storage conditions and packaging requirements.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"67:1-67:185;9970-10154\">Solubility and Dispersibility confirm that spray-dried and instant herbal powders reconstitute completely in the specified volume of water within the specified time at each Pull Point.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"69:1-69:211;10156-10366\">Residual Solvent (if spray drying uses organic solvents): Measured by GC-Headspace per ICH Q3C. This test is required when the extract is produced using ethanol or other Class 2 or Class 3 solvents per ICH Q3C.<\/li>\r\n<\/ul>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b814fdf36a\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b814fdf36a wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"testing_parameters_for_herbal_syrup\"><\/span>Testing Parameters for Herbal Syrup<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<ul>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"73:1-73:290;10410-10699\">pH is measured by pH Meter at each Pull Point. The acceptance criterion for most Herbal Syrups is 3.5 to 5.5, with a maximum change of plus or minus 0.5 units from the initial measurement. pH values outside this range indicate decomposition of the acid buffer system or microbial activity.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"75:1-75:312;10701-11012\">Brix (Total Soluble Solids) is measured by Digital Refractometer at each Pull Point. The acceptance criterion for most Herbal Syrups is 50 to 70\u00b0Bx. A Brix drop of more than 5% from the initial value indicates sucrose inversion or dilution from moisture ingress, and predicts a reduction in microbial stability.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"77:1-77:293;11014-11306\">Viscosity is measured by Brookfield Viscometer or Rotational Rheometer at each Pull Point. Viscosity change indicates degradation of the suspending agent polymer (Xanthan Gum, Carbomer, or Carrageenan), which affects both product pourability and the Sedimentation Rate of suspended particles.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"79:1-79:247;11308-11554\">Sedimentation Rate is assessed by measuring the height of the sediment layer after allowing the sample to stand for a defined period. Products with increasing sedimentation over the shelf life require re-evaluation of the suspending agent system.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"81:1-81:510;11556-12065\">Preservative Efficacy Test (PET) per ISO 11930 is conducted at T0 and at the last Pull Point to confirm that the preservative system remains effective throughout the shelf life. PET requires inoculation of the product with defined concentrations of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus brasiliensis and measurement of viable cell counts over 28 days. Category A or Category B acceptance criteria apply depending on the intended use of the product.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"83:1-83:215;12067-12281\">Total Microbial Count, Total Combined Yeast and Mold Count, and absence of specified pathogens (E. coli, S. aureus, Salmonella spp.) are assessed at each Pull Point per THP 2021 or USP microbial limit requirements.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"85:1-85:321;12283-12603\">In-use Stability testing simulates the repeated opening, closing, and dosing of the syrup bottle over the in-use period. Samples are subjected to repeated air exposure and temperature cycling to confirm that microbial quality and Marker Compound content are maintained throughout the in-use period declared on the label.<\/li>\r\n<\/ul>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b816a84507\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b816a84507 wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"marker_compound_hplc_and_volatile_compound_analysis\"><\/span>Marker Compound HPLC and Volatile Compound Analysis<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"89:1-89:151;12663-12813\">TIBD and VISBIO apply compound-specific HPLC methods validated as Stability Indicating methods for all registered Marker Compounds in the formulation.<\/p>\r\n\r\n<ul>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"91:1-91:217;12815-13031\">Andrographolide (225 nm): Primary Marker Compound for Andrographis paniculata syrups, including cough and respiratory formulas. The method resolves Andrographolide from its acid hydrolysis product Andrographolactone.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"93:1-93:254;13033-13286\">Curcuminoids (425 nm): Primary Marker Compounds for Curcuma longa (Khamin Chan) syrups. Curcuminoids are unstable in aqueous solution, particularly at alkaline pH, and degrade rapidly above pH 7. The HPLC method resolves all three curcuminoid fractions.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"95:1-95:275;13288-13562\">Glycyrrhizin (254 nm): Primary Marker Compound for syrups containing Glycyrrhiza glabra (licorice). Glycyrrhizin undergoes acid hydrolysis to Glycyrrhetic Acid under the acidic conditions of herbal syrups; the HPLC method resolves both the parent glycoside and its aglycone.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"97:1-97:95;13564-13658\">Asiaticoside (ELSD or 200 nm): Primary Marker Compound for Centella asiatica (Bua Bok) syrups.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"99:1-99:106;13660-13765\">Berberine (280 nm): Primary Marker Compound for syrups containing Coptis chinensis or Phellodendron bark.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"101:1-101:402;13767-14168\">Volatile Compound analysis by GC-MS Headspace: Measures the content and composition of volatile Terpenes, Phenylpropanoids, and Sesquiterpenes in aromatic herbal syrups such as Zingiber officinale (ginger), Cinnamomum verum (cinnamon), and Ocimum sanctum (holy basil). Changes in the volatile compound profile indicate aroma degradation and are used to set the shelf life for aroma-sensitive products.<\/li>\r\n<\/ul>\r\n[\/vc_column_text][vc_single_image image=&#8221;19006&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;&#8221; parallax_scroll=&#8221;no&#8221; woodmart_inline=&#8221;no&#8221;][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b818061987\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b818061987 wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"testing_conditions_and_pull_point_schedule_per_ich_q1ar2\"><\/span>Testing Conditions and Pull Point Schedule per ICH Q1A(R2)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"105:1-105:296;14235-14530\">Long-term Stability testing uses 30\u00b0C \/ 75% RH conditions per ASEAN Zone IVb for a minimum of 24 months. Accelerated Stability testing uses 40\u00b0C \/ 75% RH for 6 months. Intermediate Stability at 30\u00b0C \/ 65% RH is added for syrups showing significant pH or Brix change under Accelerated conditions.<\/p>\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"107:1-107:157;14532-14688\">Standard Pull Points for Long-term testing are months 0, 3, 6, 9, 12, 18, and 24. Standard Pull Points for Accelerated testing are months 0, 1, 2, 3, and 6.<\/p>\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"109:1-109:200;14690-14889\">In-use Stability testing is conducted under ambient conditions (25\u00b0C \u00b1 2\u00b0C \/ 60% RH \u00b1 5% RH) for the In-use period declared on the label, typically 4 to 8 weeks for liquid syrups after first opening.<\/p>\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"111:1-111:229;14891-15119\">DVS Sorption Isotherm is conducted at T0 for Herbal Powder formulations to generate the full moisture sorption curve and calculate Critical Relative Humidity, which informs packaging specification and storage condition labeling.<\/p>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b8192ec768\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b8192ec768 wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"formulation_and_packaging_design_consultation\"><\/span>Formulation and Packaging Design Consultation<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"115:1-115:175;15173-15347\">TIBD provides formulation consultation for manufacturers seeking to improve the stability of their Herbal Powder or Syrup product before committing to a full stability study.<\/p>\r\n\r\n<ul>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"117:1-117:418;15349-15766\">For Herbal Powder: Carrier selection for spray drying (Maltodextrin DE 10-20, Gum Arabic, Inulin, or Beta-Cyclodextrin) affects both encapsulation efficiency and hygroscopicity. Beta-Cyclodextrin is used for volatile compound encapsulation in aromatic herbal powders. Anti-caking agents including Silicon Dioxide (aerosol), Magnesium Stearate, or Calcium Silicate reduce hygroscopicity and improve powder flowability.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"119:1-119:506;15768-16273\">For Herbal Syrup: Preservative selection must balance microbial efficacy with regulatory requirements. Sodium Benzoate (as benzoic acid, effective below pH 4.5) and Potassium Sorbate (effective up to pH 6.5) are the most widely accepted preservatives for registered herbal syrups. The combination at sub-limit concentrations provides broader spectrum coverage than either agent alone. pH adjustment to 3.5 to 4.5 using Citric Acid or Malic Acid maximizes preservative efficacy and slows Maillard browning.<\/li>\r\n \t<li class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"121:1-121:486;16275-16760\">For Packaging: Herbal Powder in foil-laminate sachets (Alu-Alu with MOPP or metallized PET) provides maximum moisture barrier for hygroscopic powders. HDPE bottles with induction-sealed liners are used for bulk powder products. Herbal Syrups in amber PET or amber glass bottles with tamper-evident caps provide light protection and reduce photodegradation of Curcuminoids and Anthocyanins. Child-resistant closures are required for registered liquid herbal products containing ethanol.<\/li>\r\n<\/ul>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b81aadb8b6\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b81aadb8b6 wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"visbios_role_as_an_independent_quality_assurance_verifier_iqav\"><\/span>VISBIO&#8217;s Role as an Independent Quality Assurance Verifier (IQAV)<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]VISBIO, acting as Independent Quality Assurance Verifier (IQAV), conducts Moisture Content, Water Activity, pH, Brix, Viscosity, Microbiology including PET per ISO 11930, Marker Compound Assay by HPLC, and GC-MS Volatile Compound analysis on samples collected at each Pull Point, using Validated Methods per ICH Q2(R1) with full Traceability documentation at every step and operations conducted under ISO\/IEC 17025 standards.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t<div id=\"wd-6a4b81b7a7957\" class=\"title-wrapper wd-wpb wd-set-mb reset-last-child  wd-rs-6a4b81b7a7957 wd-title-color-white wd-title-style-simple text-left  wd-underline-colored\">\n\t\t\t\n\t\t\t<div class=\"liner-continer\">\n\t\t\t\t<h4 class=\"woodmart-title-container title  wd-font-weight-500 wd-fontsize-xxl\" ><span class=\"ez-toc-section\" id=\"tibd_team_expertise\"><\/span>TIBD Team Expertise<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\n\t\t[vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"129:1-129:612;17287-17898\">The Herbal Powder and Syrup Stability Testing service is conducted in partnership with Dr. Wuttipong Panitsettakorn, Advisor and Co-Founder, who specializes in commercial technology management for the health and beauty industry, and Ms. Mandhamon Uttamo, Advanced Formulator, who has extensive experience in the development of Thai traditional medicine and herbal supplement products across multiple dosage forms. Our team includes researchers specializing in Phytochemistry, Liquid Formulation Technology, Spray Drying Process, Microbiology, and Stability Indicating HPLC method development for herbal actives.<\/p>\r\n<p class=\"font-claude-response-body break-words whitespace-normal\" data-sourcepos=\"131:1-131:162;17900-18061\">Is your Herbal Powder or Syrup ready for Thai FDA registration or ASEAN export? <a href=\"https:\/\/www.tibdglobal.com\/en\/contact-us\/\"><span style=\"color: #ff9900;\"><strong>Contact TIBD<\/strong><\/span><\/a> for a customized stability protocol and starting price from \u0e3f15,000.<\/p>\r\n[\/vc_column_text]<div id=\"wd-6a4b81d44acbd\" class=\" wd-rs-6a4b81d44acbd  wd-button-wrapper text-center\"><a href=\"https:\/\/www.tibdglobal.com\/en\/contact-us\/\" title=\"\" target=\"_blank\" class=\"btn btn-style-default btn-shape-rectangle btn-size-default tibi-button orange\">Contact Us<\/a><\/div>[\/vc_column][\/vc_row][\/vc_section][vc_row css=&#8221;.vc_custom_1781690994140{background-color: #000000 !important;border-radius: 30px !important;}&#8221; woodmart_css_id=&#8221;6a32726c7706b&#8221; responsive_spacing=&#8221;eyJwYXJhbV90eXBlIjoid29vZG1hcnRfcmVzcG9uc2l2ZV9zcGFjaW5nIiwic2VsZWN0b3JfaWQiOiI2YTMyNzI2Yzc3MDZiIiwic2hvcnRjb2RlIjoidmNfcm93IiwiZGF0YSI6eyJ0YWJsZXQiOnt9LCJtb2JpbGUiOnt9fX0=&#8221; mobile_bg_img_hidden=&#8221;no&#8221; tablet_bg_img_hidden=&#8221;no&#8221; woodmart_parallax=&#8221;0&#8243; woodmart_gradient_switch=&#8221;no&#8221; woodmart_box_shadow=&#8221;no&#8221; wd_z_index=&#8221;no&#8221; woodmart_disable_overflow=&#8221;0&#8243; row_reverse_mobile=&#8221;0&#8243; row_reverse_tablet=&#8221;0&#8243;][vc_column][vc_column_text css=&#8221;&#8221; woodmart_inline=&#8221;no&#8221; text_larger=&#8221;no&#8221;]<span style=\"text-decoration: underline;\"><span style=\"color: #ffffff;\"><b>References<\/b><\/span><\/span>\r\n<ul>\r\n \t<li><span style=\"font-weight: 400;\">International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). Stability testing of new drug substances and products: Q1A(R2). ICH Harmonised Tripartite Guideline. <\/span><a href=\"https:\/\/database.ich.org\/sites\/default\/files\/Q1A%28R2%29%20Guideline.pdf\"><span style=\"font-weight: 400;\">https:\/\/database.ich.org\/sites\/default\/files\/Q1A%28R2%29%20Guideline.pdf<\/span><\/a><\/li>\r\n \t<li><span style=\"font-weight: 400;\">Royal Thai Government Gazette. (2019, April 30). Herbal Products Act B.E. 2562 (2019). Royal Thai Government Gazette, 136(56 Kor), 1\u201329. (In Thai)<\/span><\/li>\r\n \t<li><span style=\"font-weight: 400;\">International Organization for Standardization. (2019). Cosmetics \u2014 Microbiology \u2014 Evaluation of the antimicrobial protection of a cosmetic product (ISO 11930). <\/span><a href=\"https:\/\/www.iso.org\/standard\/75058.html\"><span style=\"font-weight: 400;\">https:\/\/www.iso.org\/standard\/75058.html<\/span><\/a><\/li>\r\n \t<li><span style=\"font-weight: 400;\">Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health. (2021). Thai Herbal Pharmacopoeia 2021. Department of Medical Sciences. <\/span><a href=\"https:\/\/bdn-thp.dmsc.moph.go.th\/home\"><span style=\"font-weight: 400;\">https:\/\/bdn-thp.dmsc.moph.go.th\/home<\/span><\/a><\/li>\r\n \t<li><span style=\"font-weight: 400;\">Royal Thai Government Gazette. (2013, May 22). Notification of the Ministry of Public Health (No. 364) B.E. 2556 (2013) Re: Standards for Pathogenic Microorganisms in Food. Royal Thai Government Gazette. (In Thai)<\/span><\/li>\r\n<\/ul>\r\n[\/vc_column_text][\/vc_column][\/vc_row]<\/div>","protected":false},"excerpt":{"rendered":"excerpt","protected":false},"featured_media":18820,"template":"","meta":{"episode_type":"","audio_file":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","date_recorded":"","explicit":"","block":"","itunes_episode_number":"","itunes_title":"","itunes_season_number":"","itunes_episode_type":"","filesize_raw":""},"product_brand":[],"product_cat":[224,223],"product_tag":[],"class_list":{"0":"post-19145","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-ingredient-modification-en","7":"product_cat-product-development-en","9":"first","10":"instock","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"tibi_services_grid_image":"","_links":{"self":[{"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/product\/19145","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/media\/18820"}],"wp:attachment":[{"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/media?parent=19145"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/product_brand?post=19145"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/product_cat?post=19145"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.tibdglobal.com\/en\/wp-json\/wp\/v2\/product_tag?post=19145"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}