phcoker Powder Alarelin (Synthetic) Certificate of Analysis CAS 79561-22-1

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

Alarelin Powder (Synthetic) 79561-22-1

Batch No. Specification

1kg

Mfg. Date

2019.01.16

Expiry Date

20190115 In-house 2019.01.15 2021.01.16

Sequence:Glp-His-Trp-Ser-Tyr-DAla-Leu-Arg-Pro-NHEt

Test Items

Specification

Test Results

Appearance

White or off-white powder

White powder

Solubility

Sparingly soluble in MeOH, soluble in water and 1% acetate

Sparingly soluble in MeOH,

acid

soluble in water and 1% acetate acid

The principal peak in the chromatogram obtained with the test HPLC

Amino acid analysis

solution is similar in retention time to principal peak in the Conforms chromatogram obtained with the reference solution. Arg

0.9-1.1

Arg

0.9

Ala

0.9-1.1

Ala

1.0

His

0.9-1.1

His

1.0

Leu

0.9-1.1

Leu

0.9

Pro

0.8-1.0

Pro

1.0

Tyr

0.9-1.1

Tyr

1.0

Glu

0.9-1.1

Glu

1.0

Ser

0.7-1.0

Ser

0.8

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

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

MS Related Substances

1167.3Âą1.0 Unspecified impurity for each impurity: NMT1.0%

1166.4 0.51%(single largest impurity)

purity

NLT 98.0%

99.26%

Acetic acid

NMT12.0%

8.3%


Water

NMT 7.0%

4.6%

Bacterial endotoxins

Less than 70IU/mg

Conforms

97.0%-103.0%

Assay

(anhydrous and acetic acid free subtance)

99.0%

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

Checker: LV

Q.C.Director: ZhangLi


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