HISTIDINE (L) MONOHYDROCHLORIDE, MONOHYDRATE BIOTECH, Synthetic
EP, JP, LBLE*, GMP
Product Code: LHMM-6250 / BBS
*Low Bioburden, Low Endotoxin
Product Inquiry COAs Spec Sheet
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
≤ 0.02% | ||
|
Passes Test | ||
| Appearance and Color | White crystalline powder or crystals | ||
|
98.5 – 101.0% | ||
| Assay, Anhydrous Basis (JP) | 99.0 – 101.0% | ||
| Bioburden | < 100 CFU/g | ||
| Endotoxin | < 100 CFU/g | ||
| Identification, Specific Optical Rotation (EP/A) | +9.2° to +10.6° | ||
| Identification B, pH (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 | ||
| Iron (EP, JP) | ≤ 10 ppm | ||
| Heavy Metals (JP) | ≤ 10 ppm | ||
| Loss on Drying (EP) | 7.0 – 10.0% | ||
|
≤ 0.2% ≤ 0.5% |
||
| Optical Rotation (JP) | +9.2° to +10.6° | ||
| pH (JP) | 3.5 – 4.5 | ||
| Related Substances (JP) | Passes Test | ||
| Residue on Ignition/ Sulfated Ash (EP, JP) | ≤ 0.1% | ||
| Sulfates (EP) | ≤ 300ppm | ||
| Sulfates (JP) | ≤ 280ppm | ||
| Clarity and Color of Solution (JP) | Clear and Colorless | ||
| Water, KF (JP) | 7.2 – 10.0% |
Molecular Formula: C6H9N3O2 •HCl • H2O
Molecular Weight: 209.64 g/mol.
CAS Number: 5934-29-2
Each Certificate of Analysis (CofA) will contain a 2-year retest/recertification date supported by a 3-year ICH Q1 Stability Study (if one is completed).
Please refer to the SDS for storage and shipping conditions.
100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg
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.