Certificate of Analysis

17α-Hydroxy Progesterone Acetate

Product:

Batch No.: 035-20100501H Mfg. Date: 2010-04-06 Analysis Date: 2010-05-22

Quantity: 10g CAS No.: 302-23-8 Retest Date: 2013-04-05

In-house
Storage: Preserve in tight, light-resistant containers. Standard: Standard

ITEM AND RESULT

Item Specification Result

Ivory-white crystalline Ivory-white crystalline
Appearance substance substance
HPLC
Identification IR Complies

Loss on drying ≤0.5% 0.1%

Specific optical rotation +58°~+62° +59.2°

Sulphated ash ≤0.10% Complies

17α-Hydroxyprogesterone ≤0.5% 0.1%

Chromatographic △6-Hydroxyprogesterone
purity acetate ≤0.1% 0.1%

Unknown impurity ≤0.10% 0.09%

Methanol ≤3000ppm 114 ppm

Ethanol ≤5000ppm 35ppm

Residual Solvents
Dichloromethane ≤600ppm 278 ppm
(GC)
Pyridine ≤200ppm 6ppm

Acetate acid ≤5000ppm 58ppm

Assay(HPLC) 98.0%~102.0% 99.1%

Conclusion: Complies with In-house Standard

Analysed by: Chief of QC: Chief of QA:

Date: Date: Date: