GMP Biotech Product
HISTIDINE (L) MONOHYDROCHLORIDE, MONOHYDRATE BIOTECH
EP, JP, LBLE*, GMP
*Low Bioburden, Low Endotoxin
COAs Spec Sheet
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 | ||
|---|---|---|---|
|
≤ 0.02% | ||
|
Passes Test | ||
|
98.5 – 101.0% | ||
| Identification A, Specific Optical Rotation (dried substance) (EP) |
+9.2° to +10.6° | ||
| Identification B, pH (EP) | 3.0 – 5.0 | ||
| Identification C, IR (EP, JP) | Passes Test | ||
| Identification D (EP) | Passes Test | ||
| Identification E (EP) | Passes Test | ||
| Identification F (EP) | Passes Test | ||
| Iron (EP, JP) | ≤ 10 ppm | ||
| Loss on Drying (EP) | 7.0 – 10.0% | ||
|
≤ 0.2% ≤ 0.5% |
||
| Residue on Ignition/ Sulfated Ash (EP, JP) | ≤ 0.1% | ||
| Sulfates (EP) | ≤ 300ppm | ||
| Assay (anhydrous basis) (JP) | 99.0 – 101.0% | ||
| Clarity and Color of Solution (JP) | Clear and Colorless | ||
| Identification 2, Chloride (JP) | Passes Test | ||
| Heavy Metals (JP) | ≤ 10 ppm | ||
| Optical Rotation (JP) | +9.2° to +10.6° | ||
| pH (JP) | 3.5 – 4.5 | ||
| Related Substances (JP) | Passes Test | ||
| Sulfates (JP) | ≤ 280 ppm | ||
| Water (JP) | 7.2 – 10.0% | ||
| Appearance and Color | White or colorless crystalline powder crystals | ||
| Bioburden | < 100 CFU/g | ||
| Endotoxin | < 100 CFU/g |
General Product Description:
Molecular Formula: C6H9N3O2 •HCl • H2O
Molecular Weight: 209.64 g/mol.
CAS Number: 5934-29-2
L-Histidine Monohydrochloride, Monohydrate Biotech:
- Appears as a white crystalline product.
- Is manufactured under an ISO Quality Managed cGMP System
- Manufactured in an enzyme free, hormone free and animal free environment
- Has 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:
Three-year expiry from the date of manufacture.
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.