GMP Manufactured Product
HISTIDINE(L) Monohydrochloride
*Low Bioburden, Low Endotoxin
L-Histidine Monohydrochloride, Monohydrate has been manufactured for use as a critical process chemical for downstream biological drug manufacturing. L-Histidine Monohydrochloride, Monohydrate has been manufactured and purified under strict ICH-Q7 guidelines for excipient materials and can be considered an excipient grade product.
CAS #: 5934-29-2
Formula: C6H9N3O2 • H2O
Sol. In H2O (g/L): 149.55
F.W.: 209.64 g/mol
pH @ 20°C: 4.38 - 4.48
Product Specifications
| EP COMPENDIA | |||
|---|---|---|---|
| ANALYSIS | SPECIFICATIONS | ||
|
≤ 0.02% | ||
|
Passes Test | ||
|
99.0 - 101.0% | ||
| Identification A, Specific Optical Rotation (dried substance) |
+9.2° to +10.6° | ||
| Identification B, pH | 3.0-5.0 | ||
| Identification C, IR | Passes Test | ||
| Identification D | Passes Test | ||
| Identification E | Passes Test | ||
| Identification F | Passes Test | ||
| Iron | ≤ 10 ppm | ||
| Loss on Drying | 7.0-10.0% | ||
| Ninhydrin-positive substances
Any Individual Impurity
Total Impurities |
≤0.2% ≤0.5% |
||
| Residue on Ignition/ Sulfated Ash |
≤0.1% | ||
| Sulfates | ≤300ppm | ||
| JP COMPENDIA | |||
|---|---|---|---|
| ANALYSIS | SPECIFICATIONS | ||
|
≤ 0.02% | ||
|
99.0-101.0% | ||
| Clarity and Color of Solution | Clear and Colorless | ||
| Identification 1, IR | Passes Test | ||
| Identification 2, Chloride | Passes Test | ||
| Heavy Metals | ≤ 10ppm | ||
| Iron | ≤ 10ppm | ||
| Loss on Drying | NMT 0.20% | ||
| Optical Rotation | +9.2° to +10.6° | ||
| pH | 3.5-4.5 | ||
| Related Substances | Passes test | ||
| Residue on Ignition/ Sulfated Ash |
≤0.1% | ||
| Sulfates | ≤280ppm | ||
| Water | 7.2-10.0% | ||
| ADDITIONAL ANALYSES | |
|---|---|
| ANALYSIS | SPECIFICATIONS |
| Appearance and Color | White or colorless crystalline powder crystals |
| Bioburden | ≤100CFU/g |
| Endotoxin | ≤100EU/g |
General Product Description:
- L-Histidine Monohydrochloride, Monohydrate, LHMM-4250, is produced at our cGMP platform in India and then shipped to our Bangor, PA facility where it is tested and repackaged under cGMP conditions.
- L-Histidine Monohydrochloride, Monohydrate is a White Crystalline product.
- Molecular Formula: C6H9N3O2 •HCl • H2O
- Molecular Weight: 209.64 g/mol.
- CAS Number: 5934-29-2
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all L-Histidine Monohydrochloride, Monohydrate, LHMM-4250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
- L-Histidine Monohydrochloride, Monohydrate manufactured at our cGMP platform in India and any raw materials used in the manufacture of L-Histidine Monohydrochloride, Monohydrate at BioSpectra are not subject to genetic modification.
- Synonyms: L-α-Amino-β-(4-imidazolyl)propionic acidmonochloride; 4-Hydroxy-2-methyl-1,1-dioxo-N-(pyridin-2-yl)-1, 2-dihydro-1lamb; da6,2- benzothiazine-3-carboxamide.
GMP Compliance:
Bio Pharma Grade L-Histidine Monohydrochloride Monohydrate, LHMM-4250, is suitable for use as an excipient. It is manufactured in accordance with International Organization for Standardization (ISO) registered Quality Managed Systems This grade of L-Histidine Monohydrochloride Monohydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
Retest Date:
The recommended retest period for L-Histidine, Monohydrochloride, Monohydrate is two years from the date of manufacture.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
10kg, 25kg and 50kg pails.
Country of Origin
India
This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.
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.