{"id":19153,"date":"2026-06-17T17:37:21","date_gmt":"2026-06-17T10:37:21","guid":{"rendered":"https:\/\/www.tibdglobal.com\/product\/herbal-sub-form-stability\/"},"modified":"2026-10-01T15:25:07","modified_gmt":"2026-10-01T08:25:07","slug":"herbal-sub-form-stability","status":"publish","type":"product","link":"https:\/\/www.tibdglobal.com\/en\/product\/herbal-sub-form-stability\/","title":{"rendered":"Herbal Product Sub-Form Stability Testing Service"},"content":{"rendered":"
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The Thai Herbal Product Act B.E. 2562 (2019) classifies registered herbal products into 14 sub-form categories covering solid oral dosage forms, liquid oral dosage forms, topical preparations, inhalation and spray products, and granules and powder formats. Each sub-form category has its own stability-critical parameters, pharmacopoeial acceptance criteria, and regulatory documentation requirements for Thai FDA registration. Manufacturers producing herbal products across multiple dosage form categories require a stability testing partner who understands the technical requirements of each sub-form and can design an appropriate stability protocol per ICH Q1A(R2) for the ASEAN Zone IVb climate.<\/p>\r\n

TIBD’s Herbal Sub-Form Stability Testing service covers all 14 dosage form categories recognized under B.E. 2562, applying Thai Herbal Pharmacopoeia 2021 (THP 2021) as the primary acceptance criteria reference, supplemented by USP, EP, BP, and Chinese Pharmacopoeia where THP 2021 does not provide a relevant monograph, and by In-house Specification developed per WHO stability testing guidelines and ICH Q1A(R2) where no pharmacopoeial standard is available. Testing is conducted in partnership with VISBIO as an Independent Quality Assurance Verifier (IQAV) operating under ISO\/IEC 17025 standards.<\/p>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t

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<\/span>Dosage Form Classification Under the Thai Herbal Product Act B.E. 2562<\/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=”” woodmart_inline=”no” text_larger=”no”]\r\n

The 14 sub-form categories under B.E. 2562 cover five major format groups: Solid Oral, Liquid Oral, Topical, Inhalation and Spray, and Granules and Powder.<\/p>\r\n\r\n

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  • Solid Oral Sub-Forms include Plain Tablet (\u0e22\u0e32\u0e40\u0e21\u0e47\u0e14\u0e18\u0e23\u0e23\u0e21\u0e14\u0e32), Film-Coated Tablet (\u0e22\u0e32\u0e40\u0e21\u0e47\u0e14\u0e40\u0e04\u0e25\u0e37\u0e2d\u0e1a\u0e1f\u0e34\u0e25\u0e4c\u0e21), Sugar-Coated Tablet (\u0e22\u0e32\u0e40\u0e21\u0e47\u0e14\u0e40\u0e04\u0e25\u0e37\u0e2d\u0e1a\u0e19\u0e49\u0e33\u0e15\u0e32\u0e25), Hard Gelatin Capsule (\u0e22\u0e32\u0e41\u0e04\u0e1b\u0e0b\u0e39\u0e25\u0e41\u0e02\u0e47\u0e07), Soft Gelatin Capsule (\u0e22\u0e32\u0e41\u0e04\u0e1b\u0e0b\u0e39\u0e25\u0e19\u0e34\u0e48\u0e21), Softgel (\u0e0b\u0e2d\u0e1f\u0e40\u0e08\u0e25), and Traditional Lycap (\u0e25\u0e39\u0e01\u0e01\u0e25\u0e2d\u0e19). Each of these sub-forms has distinct compendial test methods, acceptance criteria, and stability-critical parameters as detailed in the individual service pages for Herbal Tablet, Capsule, and Softgel stability testing.<\/li>\r\n \t
  • Liquid Oral Sub-Forms include Herbal Syrup (\u0e22\u0e32\u0e19\u0e49\u0e33\u0e40\u0e0a\u0e37\u0e48\u0e2d\u0e21), Herbal Oral Solution (\u0e22\u0e32\u0e19\u0e49\u0e33\u0e43\u0e2a), and Herbal Suspension (\u0e22\u0e32\u0e19\u0e49\u0e33\u0e41\u0e02\u0e27\u0e19\u0e15\u0e30\u0e01\u0e2d\u0e19). Testing parameters for Liquid Oral sub-forms include pH, Brix, Viscosity, Sedimentation Rate, Clarity, Microbiology, Preservative Efficacy Test (PET) per ISO 11930, and Marker Compound Assay by HPLC throughout the shelf life.<\/li>\r\n \t
  • Topical Sub-Forms include Herbal Cream and Lotion (\u0e04\u0e23\u0e35\u0e21\u0e41\u0e25\u0e30\u0e42\u0e25\u0e0a\u0e31\u0e48\u0e19), Herbal Balm and Ointment (\u0e22\u0e32\u0e2b\u0e21\u0e48\u0e2d\u0e07\u0e41\u0e25\u0e30\u0e02\u0e35\u0e49\u0e1c\u0e36\u0e49\u0e07), and Herbal Transdermal Patch (\u0e41\u0e1c\u0e48\u0e19\u0e41\u0e1b\u0e30\u0e1c\u0e34\u0e27\u0e2b\u0e19\u0e31\u0e07). Testing parameters for Topical sub-forms include Viscosity, pH, Emulsion Stability (Phase Separation, Creaming), Skin Adhesion for Patches, Drug Release Profile by Franz Diffusion Cell, Microbiology including Preservative Efficacy Test, and Marker Compound Assay by HPLC.<\/li>\r\n \t
  • Inhalation and Spray Sub-Forms include Herbal Nasal Spray and Aromatherapy Spray (\u0e22\u0e32\u0e2a\u0e40\u0e1b\u0e23\u0e22\u0e4c\u0e09\u0e35\u0e14\u0e1e\u0e48\u0e19). Testing parameters include Spray Pattern uniformity, Particle Size Distribution for aerosol products, pH, Microbiology, Volatile Compound stability by GC-MS, and Marker Compound Assay.<\/li>\r\n \t
  • Granules and Powder Sub-Forms include Herbal Granule (\u0e22\u0e32\u0e1c\u0e07\u0e40\u0e21\u0e47\u0e14) and Herbal Powder Sachet (\u0e22\u0e32\u0e1c\u0e07\u0e0b\u0e2d\u0e07). Testing parameters include Moisture Content, Water Activity, Particle Size Distribution, Hygroscopicity by DVS Sorption Isotherm, Solubility, Microbiology, and Marker Compound Assay by HPLC.<\/li>\r\n<\/ul>\r\n[\/vc_column_text][vc_single_image image=”19014″ img_size=”full” alignment=”center” css=”” parallax_scroll=”no” woodmart_inline=”no”][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t
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    <\/span>Common Stability Challenges Across Sub-Forms in Tropical Climates<\/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=”” woodmart_inline=”no” text_larger=”no”]\r\n

    Seven stability challenges are common to multiple herbal product sub-forms when stored under ASEAN Zone IVb conditions of 30\u00b0C \/ 75% RH long-term and 40\u00b0C \/ 75% RH accelerated.<\/p>\r\n\r\n

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    1. The first common challenge is Marker Compound degradation. All herbal product sub-forms containing standardized extract with a declared Marker Compound content must demonstrate that the content remains at Not Less Than 90% of the labeled value throughout the declared shelf life. Degradation rates vary by sub-form: liquid oral preparations generally show faster degradation than solid dosage forms due to greater molecular mobility in aqueous solution.<\/li>\r\n \t
    2. The second common challenge is moisture-related physical instability. Solid sub-forms including Tablets, Capsules, Granules, and Powders absorb moisture from the humid ambient environment, increasing Disintegration Time, reducing Hardness, causing Caking, and promoting microbial growth. Liquid sub-forms may undergo concentration change through evaporation or dilution by condensed moisture. Topical sub-forms may exhibit phase separation or viscosity change from moisture ingress.<\/li>\r\n \t
    3. The third common challenge is microbial growth under tropical storage conditions. All liquid and semi-solid herbal sub-forms require Microbial Limit testing and Preservative Efficacy testing at each Pull Point. The hot and humid ASEAN Zone IVb environment accelerates microbial growth in water-containing formulations with inadequate preservative systems.<\/li>\r\n \t
    4. The fourth common challenge is color change from oxidation of natural pigments, Maillard reaction, or enzyme-catalyzed browning. Color assessment by CIE La<\/em>b* Colorimetry is applied to all sub-forms where color is a quality indicator, including Tablets, Capsules, Syrups, Creams, and Patches.<\/li>\r\n \t
    5. The fifth common challenge is pH change in liquid sub-forms from acid production by microbial activity, hydrolysis of ester or glycoside bonds, or oxidation reactions. pH monitoring at each Pull Point provides an early indicator of chemical or microbial instability in all liquid oral and topical sub-forms.<\/li>\r\n \t
    6. The sixth common challenge is aroma and volatile compound loss from aromatic herbal products, including essential oil-containing syrups, balms, patches, and sprays. Volatile Compound stability is monitored by GC-MS headspace analysis for products where aroma is a quality attribute.<\/li>\r\n \t
    7. The seventh common challenge is packaging integrity failure under tropical temperature cycling. Blister seal integrity, bottle closure performance, sachet seal strength, and tube closure reliability must all be confirmed throughout the shelf life under ASEAN Zone IVb conditions. Packaging integrity failure results in moisture ingress, microbial contamination, and active ingredient loss regardless of formulation quality.<\/li>\r\n<\/ol>\r\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]\n\t\t
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      <\/span>Sub-Form-Specific Testing Parameters by Category<\/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=”” woodmart_inline=”no” text_larger=”no”]\r\n