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Xuchang Shangke Chemical Co., Ltd. CERTIFICATE OF ANALYSIS Product Name

CAS No. Quantity Date of Analysis

Triptorelin Acetate Powder (Synthetic) 140194-24-7

Batch No.

Specification

1kg

Mfg. Date

2018.12.12

Expiry Date

20181211

In-house 2018.12.11 2020.12.12

Sequence: Pyr-His-Trp-Ser-Tyr-DTrp-Leu-Arg-Pro-Gly-NH2

Test Items

Specification

Test Results

Appearance

White or off-white powder

White powder

Solubility

Sparingly soluble in MeOH, 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 principal peak in the HPLC

Amino acid analysis

chromatogram obtained with the reference solution. Arg

0.9-1.1

Gly

0.9-1.1

His

0.9-1.1

Leu

0.9-1.1

Pro

0.8-1.0

Tyr

0.9-1.1

Glu

0.9-1.1

Ser

0.7-1.0

No more than the traces of the other amino acids are present. MS

Related Substances Purity(HPLC)

1311.5Âą1.0 Unspecified impurity

conforms

Arg

1.0

Gly

0.9

His

0.9

Leu

0.9

Pro

1.0

Tyr

1.0

Glu

1.0

Ser

0.8

conforms conforms

for each impurity: NMT1.0%

0.45%(single largest impurity)

NLT 98%

99.47%


Acetic acid

NMT 12.0%

7.0%

Water Content(Karl Fischer

NMT 7.0%

4.1%

Bacterial endotoxins

Less than 70IU/mg 97.0%-103.0%

Assay

(anhydrous and acetic acid free subtance)

Residual solvent Methanol

NMT 3000ppm NMT 410 ppm NMT 320 ppm

conforms

98.7 %

conforms

Acetonitrile Triethylamine

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

Checker: LV

Q.C.Director: ZhangLi

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phcoker Powder Triptorelin Acetate (Synthetic) Certificate of Analysis CAS 140194-24-7  

Triptorelin is a gonadotropin-releasing hormone agonist (GnRH agonist) used as the acetate or pamoate salts. By causing constant stimulation...

phcoker Powder Triptorelin Acetate (Synthetic) Certificate of Analysis CAS 140194-24-7  

Triptorelin is a gonadotropin-releasing hormone agonist (GnRH agonist) used as the acetate or pamoate salts. By causing constant stimulation...

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