GMP Biotech Product

HISTIDINE (L) MONOHYDROCHLORIDE, MONOHYDRATE BIOTECH, Synthetic

EP, JP, LBLE*, GMP
Product Code: LHMM-6250 / BBS

*Low Bioburden, Low Endotoxin

Product Inquiry COAs Spec Sheet

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Price per unit (INR)				Price per kilogram (INR)
100g	500g	1kg	2-5kg (1kg ea)	1x5kg	1x10kg
₹35638 ea.	₹102547 ea.	₹101344 ea.	₹188098 ea.	₹85981 /kg	₹81041 /kg

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UNIT SIZE

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100g

500g

1kg

2-5kg

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Product Code: LHMM-6250

Intended for Use in Biopharmaceutical & Biotechnological Applications and Products

L-Histidine Monohydrochloride, Monohydrate Biotech has been synthesized and purified under full GMP Conditions and meets multicompendial applications.

Formula: C₆H₉N₃O₂ •HCl • H₂O
F.W.: 209.64 g/mol
CAS #: 5934-29-2

Product Specifications

ANALYSIS

SPECIFICATIONS

Ammonium (EP/JP)

< = 200 ppm

Appearance and Color

White Crystalline Powder or Crystals

Appearance of Solution (EP)

Passes Test

Assay, Dried Basis (EP)

98.5 – 101.0%

Assay, Anhydrous Basis (JP)

99.0 – 101.0%

Microbial Content

TAMC

TYMC

< = 100 CFU/g

Clarity and Color of Solution (JP)

Clear and Colorless

Endotoxin

< = 100 EU/g

Identification A, Specific Optical Rotation (EP)

+9.2° to +10.6°

Identification B, pH (5%) (EP)

3.0 – 5.0

Identification C, IR (EP-C, JP-1)

Conforms to Reference Standard

Identification D (EP)

Passes Test

Identification E (EP)

Passes Test

Identification F (EP)

Passes Test

Identification 2, Chloride (JP)

Passes Test

Loss on Drying (EP)

7.0 – 10.0%

Ninhydrin-positive substances (EP)

Any Individual Impurity

Total Impurities

< = 0.2%

< = 0.5%

Specific Optical Rotation (JP)

+9.2° to +10.6°

pH (10%) (JP)

3.5 – 4.5

Related Substances (JP)

Passes Test

Residue on Ignition/ Sulfated Ash (EP/JP)

< = 0.1%

Sulfate

Sulfate (EP)

Sulfate (JP)

< = 300 ppm

< = 280 ppm

Trace Metals

Iron (Fe) (EP/JP)

Lead (Pb)

< = 10 ppm

Water, KF (JP)

7.2 – 10.0%

Printable Version

General Product Description:

Molecular Formula: C₆H₉N₃O₂ •HCl • H₂O
Molecular Weight: 209.64 g/mol.
CAS Number: 5934-29-2
Appears as a white crystalline powder or crystals
GMP manufactured in accordance with the certified management system
Manufactured in an enzyme free, hormone free and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product nor its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: L-α-Amino-β-(4-imidazolyl) propionic acid monochloride

Shelf Life Policy:

Unless otherwise noted on the shelf-life statement and CoA, this product has a retest date 2-years from the date of manufacture, supported by an ICH Q7 Stability Study (if one is completed).

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Sizes:

100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.