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104352 SAFCL-Histidine

EMPROVE® EXPERT Ph Eur,ChP,JP,USP

L-Histidine MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Material Qualification Dossier
Quality Management Dossier (Open Access)
Operational Excellence Dossier
SDS
CoA
Certificates

Synonyms: His

CAS #: 71-00-1 EC Number: 200-745-3 Molar Mass: 155.15 g/mol Hill Formula: C₆H₉N₃O₂ Grade: Ph Eur,ChP,JP,USP

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Overview

Replacement Information

Key Specifications Table

CAS #	EC Number	Hill Formula	Molar Mass	Grade Value
71-00-1	200-745-3	C₆H₉N₃O₂	155.15 g/mol	Ph Eur,ChP,JP,USP

Products

Catalog Number	Packaging	Qty/Pack
1043520001	Plastic bottle	3 x 500 g	Add To Favorites Add To Favorites Added To My Favorites
1043520500	Plastic bottle	0.5 kg	Add To Favorites Add To Favorites Added To My Favorites
1043521000	Plastic bottle	1 kg	Add To Favorites Add To Favorites Added To My Favorites
1043529010	Plastic drum	10 kg	Add To Favorites Add To Favorites Added To My Favorites

Description
Catalogue Number	104352
Synonyms	His

References

Product Information
CAS number	71-00-1
EC number	200-745-3
Grade	Ph Eur,ChP,JP,USP
Hill Formula	C₆H₉N₃O₂
Molar Mass	155.15 g/mol
HS Code	2933 29 92
Structure formula Image
Quality Level	MQ500

Applications

Biological Information

Physicochemical Information
Density	1.449 g/cm3 (20 °C)
Melting Point	285 °C (decomposition)
pH value	7.0 - 8 (15.5 g/l, H₂O, 25 °C)
Bulk density	430 kg/m3
Solubility	38.2 g/l

Dimensions

Materials Information

Toxicological Information
LD 50 oral	LD50 Rat > 5110 mg/kg

Safety Information according to GHS
RTECS	MS3070000
Storage class	10 - 13 Other liquids and solids
WGK	WGK 3 highly hazardous to water

Safety Information

Product Usage Statements

Storage and Shipping Information
Storage	Store at +2°C to +30°C.

Packaging Information

Transport Information

Supplemental Information

Specifications
Assay (acidimetric, calculated on dried substance)	98.5 - 101.0 %
Assay (perchloric acid titration, calculated on dried substance)	99.0 - 101.0 %
Identity (IR-spectrum)	passes test
Identity (specific rotation)	passes test
Identity (TLC)	passes test
Appearance	white to almost white fine-crystalline powder or colorless crystals
Appearance of solution (50 g/l; water)	clear and not more intense in color than reference solution BY₇.
Appearance of solution (20 g/l, water)	clear and colorless
Transmittance of solution (30 g/l, water)	≥ 98.0 %
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance)	+11.4 to +12.4
Spec. rotation (α 25/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)	+12.6 to +14.0
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)	+12.0 to +12.8
pH (20 g/l, CO₂-free water)	7.0 - 8.5
Acidity (20g/l, water)	7.0 - 8.5
Chloride (Cl)	≤ 200 ppm
Sulfate (SO₄)	≤ 200 ppm
Heavy metals (as Pb)	≤ 10 ppm
As (Arsenic)	≤ 1 ppm
Cu(Copper)	≤ 25 ppm
Fe (Iron)	≤ 10 ppm
Mn (Manganese)	≤ 25 ppm
Zn (Zinc)	≤ 130 ppm
Other amino acids (TLC)	≤ 0.5 %
Related Compounds, total (TLC)	≤ 0.5 %
Related substances (TLC)	passes test
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity)	≤ 0.2 %
Ninhydrin-positive substances (LC) (ammonium (570 nm))	≤ 0.02 %
Ninhydrin-positive substances (LC) (total impurities)	≤ 0.5 %
Residual solvents (ICH (Q3C))	excluded by manufacturing process
Sulfated ash (600 °C)	≤ 0.1 %
Loss on drying (105 °C; 3 h)	≤ 0.2 %
Bacterial endotoxins	< 2.0
Bacterial endotoxins (ChP)	< 6.0
Microbiological test (total aerobic microbial count (TAMC))	≤ 10²
Microbiological test (total yeast and mould count (TYMC))	≤ 10²
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph. Eur., ChP, JP, USP

Global Trade Item Number
Catalog Number	GTIN
1043520001	04027269365486
1043520500	04027269365042
1043521000	04022536906829
1043529010	04022536906836

Documentation

Material Qualification Dossier

Title	Version
Material Qualification Dossier	9.0

Quality Management Dossier (Open Access)

Title
Quality Management Dossier

Operational Excellence Dossier

Title
Operational Excellence Dossier

L-Histidine SDS

Title
Safety Data Sheet (SDS)

L-Histidine Certificates of Analysis

Product Number	Packaging	Specification	Lot Number
1043520001	Plastic bottle	PDF Specification Document	Enter Lot Number
1043520500	Plastic bottle	PDF Specification Document	Enter Lot Number
1043521000	Plastic bottle	PDF Specification Document	Enter Lot Number
1043529010	Plastic drum	PDF Specification Document	Enter Lot Number

Certificates

Title
Aflatoxin Certificate for 104352 L-Histidine EMPROVE® EXPERT Ph Eur,ChP,JP,USP
BSE/TSE Certificate for 104352 L-Histidine EMPROVE® EXPERT Ph Eur,ChP,JP,USP
GMO Certificate for 104352 L-Histidine EMPROVE® EXPERT Ph Eur,ChP,JP,USP
Halal Certificate for 104352 L-Histidine EMPROVE® EXPERT Ph Eur,ChP,JP,USP
Kosher Certificate for 104352 L-Histidine EMPROVE® EXPERT Ph Eur,ChP,JP,USP

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