CERTIFICATE OF ANALYSIS
PRODUCT NAME: Alendronate EP Impurity A
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Date of Mfg: Sample COA
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RETEST DATE: Sample COA
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Catalogue Number |
ALE-001
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Item/Batch Number |
Sample COA
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Quantity |
Sample COA
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CAS Number |
56-12-2
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Mol. Formula |
C4H9NO2
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Molecular Wt |
103.1 g/mol
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IUPAC |
4-Aminobutanoic acid
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Synonyms |
Glutamic Acid - Impurity D (EP/BP) (As per EP Monograph 37.3); Sodium Alendronate Trihydrate- Impurity A (EP/BP); γ-Aminobutyric Acid; 3-Carboxypropylamine; 4-Aminobutyric Acid; Aminalon; GABA; Gaballon; Gamarex; Gammalon; Gammalone;Gammar; Gammasol; Mielogen; Mielomade; Piperidic acid; Piperidinic acid; γ-Aminobutanoic acid; ω-Aminobutyric Acid; Gamma-aminobutyric Acid (USP)
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Long Term Storage Condition |
cool, dry, and well-ventilated place
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Handling instruction |
Sample COA
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Test |
Results
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Appearance |
white or off-white crystalline powder
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Water content by KF/TGA
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Sample COA
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% Potency = [100 - (Water content by KF)] X HPLC Purity)] / 100
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Sample COA
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Identification by HNMR |
Sample COA
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Identification By IR |
Sample COA
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Mass (ESI) |
Sample COA
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Solubility |
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Purity |
NLT 98%
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Analysis Date (Release Date) |
Sample COA
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Attachments |
Sample COA
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Other Information |
Sample COA
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Note: This material can be used as a referance standard and is for research purpose ONLY and not for human consumption
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This is Sample COA
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