PRODUCT SPECIFICATION

AYUFLEX®
PS# 005

Product Description: Botanical name: Terminalia chebula Solvent: Water (100% aqueous extraction)
Plant part used: Fruits Appearance: Powder with occasional lumps

TEST SPECIFICATION TEST METHOD FREQUENCY

Color: Off white to Brown

Sensory Analysis Odor: Characteristic Visual inspection Each lot
Taste: Astringent
Low Mw Hydrolysable Tannins: ≥39.0%
(w/w)
a.) Chebulinic acid + Chebulagic acid:
Assay (By HPLC) ≥27.0% (w/w) In house method Each lot
b.) Other LMwHT: ≥12.0% (w/w)
Gallic acid: Report
Ellagic acid: Report
Moisture Content ≤ 6.0 % (w/w) Karl Fischer Each lot

Water-soluble extractive value ≥ 80% (w/w) Gravimetry Each lot

Heavy Metals
Lead (Pb) ≤ 1 ppm
Arsenic (As) ≤ 1 ppm ICP-MS USP <730> Each lot
Cadmium (Cd) ≤ 0.5 ppm
Mercury (Hg) ≤ 0.5 ppm
Microbial Tests
Total Aerobic microbial count ≤ 5000 CFU/g USP <2021>
Combined Mold & Yeast ≤ 1000 CFU/g USP <2021>
E. Coli absent in 1 g USP <2022>
Each lot
Staphylococcus aureus absent in 1 g USP <2022>
Pseudomonas aeruginosa absent in 1 g USP <62>
Salmonella species absent in 10 g USP <2022>
Candida albicans absent in 1 g Custom
Pesticides As per the limit listed in USP <561> USP 40 <561> Yearly

Residual Solvents As per the limit listed in USP <467> USP <467> Yearly

Aflatoxins As per the limit listed in USP <467> USP <467> Yearly

PAH’s As specified by ISO N842 CD21035 GC-MS Yearly

Storage Condition: Store in original sealed containers at +150c to +250c, avoid exposure to light and moisture. Material is hygroscopic.
Packaging type: Packed in 3x5kg bags
Stability/Shelf-life: 3 years from the date of manufacture
Country of Origin: India & Nepal

Doc No. QA-018/R2

Reason for Revision: CCR# 004, CCR# 007 Page 1 of 1
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