Excipient
ICH-Q7 GMP Manufactured ProductL-HISTIDINE Monochloride, Monohydrate, LBLE, EP, JP, GMP Excipient Grade
Low Bioburden, Low Endotoxin, GMP Manufactured
Product Code: LHMM-3250
Intended For Use As An Excipient
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.
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% |
||
| Sulfated Ash | ≤0.1% | ||
| Sulfates | ≤300ppm | ||
| JP COMPENDIA | |||
|---|---|---|---|
| ANALYSIS | SPECIFICATIONS (EP) | ||
|
≤ 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 | ≤0.1% | ||
| Sulfate | ≤0.028% | ||
| Water | 7.2-10.0% | ||
| ADDITIONAL ANALYSES | |
|---|---|
| ANALYSIS | SPECIFICATIONS (JP) |
| Appearance and Color | White or colorless crystalline powder crystals |
| Bioburden | ≤100CFU/g |
| Endotoxin | ≤100EU/g |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
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| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
| List of C of As files |
|---|
| No files available right now. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
LHMM-3250
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
General Product Description:
- The manufacturing of Bio Excipient Grade L-Histidine, Monohydrochloride, Monohydrate, LHMM-3250 is performed at BioSpectra’s Bangor, PA facility and BioSpectra’s Rensselaer, NY facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Pharma Grade L-Histidine, Monohydrochloride, Monohydrate is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
- 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-3250 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 BioSpectra and any raw materials used in the manufacture of LHistidine, Monohydrochloride, Monohydrate at BioSpectra are not subject to genetic modification.
- Synonyms: L-α-Amino-β-(4-imidazolyl)propionic acidmonohydrochloride; 4-Hydroxy-2-methyl-1,1-dioxo-N-(pyridin-2-yl)-1, 2-dihydro-1lamb; da6,2-benzothiazine-3-carboxamide
GMP Compliance:
Bio Excipient Grade L-Histidine, Monohydrochloride, Monohydrate, LHMM-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of L-Histidine, Monohydrochloride, Monohydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for L-Histidine 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.
Additional Packaging Information
https://www.biospectra.us/technical/packaging