phcoker powder Degarelix Acetate (Synthetic) Certificate of Analysis CAS 214766-78-6

Page 1

Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name CAS No. Quantity

Date of Analysis

Degarelix Acetate Powder (Synthetic) 214766-78-6 200g

Batch No. Specification Mfg. Date

2018.12.29

Expiry Date

20181228 In-house 2018.12.28 2020.12.29

Sequence: Ac-D2Nal-D4Cpa-D3Pal-Ser-4Aph(L-Hor)-D4Aph(Cbm)-Leu-Lys(Ipr)-Pro-DAla-NH2

Test

Specification

Result

Appearance

White or off-white powder

White powder

Solubility

Soluble in water and 1% acetate acid

conforms

The principal peak in the chromatogram

obtained

with the test solution is similar in retention time to

HPLC

principal peak in the chromatogram obtained with the

conforms

reference solution. MS

1632.3Âą1.0

conforms

Related Substances

Unspecified impurity for each impurity: NMT1.0%

0.33%(single largest impurity)

Purity(HPLC)

NLT 98.0%

99.2%

Acetic acid

NMT 3.4~6.8%

4.9%

Water

NMT 7.0%

4.3%

Bacterial endotoxins

Less than 5IU/mg

conforms

97.0%-103.0%

Assay

(anhydrous and acetic acid free subtance)

98.5%

Residual solvent Methanol

NMT 3000ppm

Acetonitrile

NMT 410 ppm

Triethylamine

NMT 320 ppm

conforms

Conclusion: The test product complies with the requirements of specification. Analyst: Dai

Checker: LV

Q.C.Director: ZhangLi


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.