Certificate of Analysis

Product name: Histidine

Number of analysis: T0005106

Batch number / Weight: 19F11-H18-00811 / 5kg

Producer / Producer Batch Number: Productos Quimicos Gonmisol S.A./18101497

Analysed according to: PH.EUR 9.7

Tests Requirement Result Unit Standard remark

Appearance White to almost white, crystalline powder or colourless crystals Conform

Identification A Conform Conform Specific optical rot.
Identification B Conform Conform IR-spectrum
Appearance of solution Clear Conform 5%m/V H2O
Appearance of solution <= BY7 Conform 5%m/V H2O; DP
Specific optical rotation +11,4 - +12,4 +11,5
Ninhydrin-positive substances Conform Conform DP
Any ninhydrin-positive substance <= 0,2 0,0 %
Total <= 0,5 0,0 %
Chlorides <= 200 <= 200 ppm DP
Sulfates <= 300 <= 200 ppm DP
Ammonium <= 0,02 <= 0,02 % At 570nm; DP
Iron <= 10 <= 10 ppm DP
Loss on drying <= 0,5 0,08 % 105°C oven
Sulfated ash <= 0,1 0,04 % DP
Assay 98,5 - 101,0 100,1 %m/m Dried; DP

Analysis performed by the authorized internal lab.

Release:
Vasileios Dimitroulis
Pharmacist - QA Manager / QP

11/06/2019

Expiration: 08-10-2021

Conclusion: APPROVED

This document has been produced electronically from our quality system and is valid without signature.

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