Pharmaceutical Raw Materials Pregabalin Intermediate Treats Epilepsy 148553-50-8 With Safe Pass
Abstract
CAS:148553-50-8
MF:C8H17NO2
MW:159.23
EINECS:200-659-6
Melting point:194-196°C
alpha D23 +10.52° (c = 1.06 in water)
Flash point:9℃
storage temp. Store at RT
solubility deionized water: ≥10mg/mL
InChIKeyAYXYPKUFHZROOJ-ZETCQYMHSA-N
Description
1. Pregabalin is a new anti-epileptic drug, gamma-aminobutyrate structure in its molecular structure, with anticonvulsant effects, and successful development of the company’s treatment of peripheral neuropathic pain, or partial seizures. In December 2008, the US Food and Drug Administration (FDA) approved Pregabalin (trademark Lyrica) for the treatment of diabetic peripheral neuropathic pain (DPN) and post-heat pain neuralgia (PHN), both of which are the most Common neuropathic pain.
2. Neuropathic pain is one of the most difficult treatments for chronic pain syndrome. It is a major feature of relieving pain, burning, and tingling. There are many nerve pains, diabetes, infections (such as herpes zoster), cancer and AIDS that can cause nerve pain. About 3% of the population in Europe suffer from neuralgia and torture.
Applicant
Pregabalin, also known as beta-isobutyl-aminobutyric acid (beta-isobutyl-GABA), is a drug used to treat epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder. Common side effects include: lethargy, confusion, memory impairment, poor coordination, dry mouth, vision problems, and weight gain. Potentially serious side effects include angioedema, drug abuse, and increased risk of suicide.
Pregabalin is primarily excluded from the systemic circulation through renal excretion as an unaltered drug. Pregabalin is mainly excreted in urine (≥98%) . Pregabalin has an average elimination half-life of 6.3 hours. 50% of patients will receive a negative urine sample within 3 days, and a total of 5 days will be required to obtain a negative urine sample of the maximum urine concentration detected in the subject.
The PGB Rapid Detection Panel (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test used a monoclonal antibody to selectively detect elevated levels of Prepabatin in the urine. Adjusting the quick test panel (urine) produces a positive result when compared to more than 50μg / ml in urine
COA:
ITEMS |
STANDARDS |
RESULTS |
Appearance |
A white to off white powder |
White powder |
Identification |
A. Meets the requirement |
Complies |
B. IR: similar to Reference Substance |
Complies |
Loss on drying |
≤0.5% |
0.21% |
Specific Rotation |
+10.0°~+13.0° |
+10.8° |
Related Substances |
Any single impurity ≤0.1%
Total impurity ≤0.8% |
0.05%
0.10% |
Purity By HPLC R-isomer |
≤0.15% |
0.10 |
Residue on ignition |
≤0.1% |
0.05% |
Residual solvents |
Isopropyl alcohol ≤5000ppm
Ethyl Acetate ≤5000ppm |
150ppm
250ppm |
Heavy metals |
≤10ppm |
Complies |
Chlorides |
≤0.05% |
Complies |
Assay |
98%~102.0% |
99.8% |
Conclusion |
Analyse according to Factory Standard , Conform |
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