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Which production standards and pharmacopoeias does this storax balsam oil comply with?

Storax balsam oil is manufactured and released against the ChP 2025 Styrax monograph as the core standard, with support from ISO, EU SCCP, Korean Pharmacopoeia, and FEMA references.

Standards & Pharmacopoeias

StandardRoleKey requirements
ChP 2025 《苏合香》 (STYRAX)Core standardSource Liquidambar orientalis; acid value 50–76; saponification value 160–190; total cinnamic acid ≥ 23.0% (HPLC); 8-peak GC fingerprint; TLC ID with cinnamyl cinnamate reference
ChP 2025 supplementSupplementaryL. orientalis / L. formosana only; cinnamyl cinnamate 18.0%–25.0%; benzyl benzoate 12.0%–18.0%; heavy metals ≤ 5 mg/kg; microbial limits; harvest season defined; fingerprint markers β-pinene / camphene / bornyl acetate
ISO 4720:2018NomenclatureItem 98: Liquidambar orientalis Mill., Hamamelidaceae, storax, exudate
EU SCCP/0872/05EU cosmetics opinionINCI names for Liquidambar balsam extract/oil; CAS 94891-27-7; EINECS 305-627-6
Korean Pharmacopoeia (outside-herb monograph)Regional recognitionLiquidambaris Storax; semi-fluid sticky liquid; loss on drying ≤ 5.0%
FEMA 3036FlavorStorax (Liquidambar spp.) — flavoring substance
GB/T 11540 / 14454.4Test methodsRelative density, refractive index
  • ChP general methods applied: 0713 (fats/lipids — acid & saponification values), 0512 (HPLC), 0521 (GC), 0502 (TLC)
  • Heavy metal total limit ≤ 5 mg/kg and compulsory microbial testing follow the ChP 2025 supplement for the oil grade
  • Production plants operate under ISO 9001 quality systems; COA/GC-MS issued per batch, and pharmacopoeia-grade documentation is available for regulatory filings

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This article was published on 2026-09-07, and last updated on 2026-09-07. The article will be continuously updated.