(Buffering Agent / Stabilizer)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility producing Glycine known for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.
Our advanced technology ensures the production of Glycine with exceptional purity and quality making it an ideal choice for use in the pharmaceutical industry.
Applications: MOLACID® GLY is used in pharmaceutical formulations as an excipient, stabilizer, buffering agent and formulation aid. It is used in tablets, capsules, oral powders, liquid preparations and injections, depending on formulation requirements. It can also function as a tonicity-adjusting agent in certain injectable and parenteral formulations. MOLACID® GLY also used in protein, amino-acid and lyophilized formulations to improve the stability of sensitive ingredients. It helps maintain pH, stability and compatibility of active pharmaceutical ingredients (APIs).
| # | PROPERTY | TYPICAL VALUE |
|---|---|---|
| 1 | CAS No | 56-40-6 |
| 2 | Molecular Formula | C2H5NO2 |
| 3 | Molecular Weight | 75.07 g/mol |
| # | TEST | SPECIFICATION - USP |
|---|---|---|
| 1 | Description | It occurs as a white, odorless, crystalline powder, having a sweetish taste. |
| 2 | Identification Test (A) |
(A) Infrared spectrophotometry. |
| 3 | Solubility | It is freely soluble in water; very slightly soluble in alcohol and in ether. |
| 4 | Residue On Ignition | Not more than 0.1%. |
| 5 | Chloride | Not more than 0.007%. |
| 6 | Sulfate | Not more than 0.0065%. |
| 7 | Hydrolysable Substances | The solution appears as clear and as mobile as 10 mL of the same solution that has not been boiled. |
| 8 | Related Compounds (A) Glycine anhydride (B) Iminodiacetic acid (C) Diglycine (D) Triglycine (E) Hexamethylenetetramine (F) Total impurities |
(A) Not more than 0.1%. (B) Not more than 0.1%. (C) Not more than 0.1%. (D) Not more than 0.1%. (E) Not more than 0.1%. (F) Not more than 1.0%. |
| 9 | Loss on drying | Not more than 0.2%. |
| 10 | Assay | Not less than 98.5% to not more than 101.0% on the dried basis. |
MOLACID® GLY is packed in HDPE bag or HDPE drum with double PE liners inside having bar-coded label and tamper-evident seal.
The shelf life is 3 years. Preserve in well-closed containers at room temperature.
This document and any information provided herein does not constitute a legally binding obligation of Muby Chem and has been prepared in good faith and is believed to be accurate as of the date of issuance. Unless expressly agreed otherwise in writing in a supply contract or other written agreement between you and Muby Chem: