GMP Manufactured Product
HISTIDINE(L) Monohydrochloride
*Low Bioburden, Low Endotoxin
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 |
≤0.2% |
||
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 |
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.
The recommended retest period for L-Histidine, Monohydrochloride, Monohydrate is two years from the date of manufacture.
Ship and Store in ambient temperature.
10kg, 25kg and 50kg pails.
India
This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.
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.