What is Raw Pregabalin Powder?
Raw Pregabalin Powder is a chemical substance that isn't uprooted from shops or natural products but is produced through synthetic chemical styles. The greasepaint is white in appearance and is in a solid state, generally in greasepaint or demitasse form. Its product and processing technology involves a series of organic conflation responses, and the final product is synthesized from raw accoutrements through chemical conflation. The main active component in it's Pregabalin Hydrochloride.
Pregabalin hydrochloride is an antiepileptic medicine that's also used to relieve neuropathic pain and anxiety diseases. It exerts its pharmacological goods by regulating the release of neurotransmitters in the nervous system, especially by inhibiting the release of glutamate. The main functions and operations are in the treatment of epilepsy, neuropathic pain, and anxiety diseases. Pure Pregabalin Powder can reduce seizure frequence and pain symptoms and ameliorate a case's quality of life. In addition, it may also have implicit operations in the treatment of other neurological conditions, but the specific goods are still being explored in exploration.
Quality Control COA
ITEMS | STANDARD | TEST RESULTS | |
Assay | 98%-102.0% | 99.62% | |
R-isomer | ≤0.5% | 0.15% | |
Physical & Chemical | |||
Identification | A: Meets the requirement B: IR: similar to reference Substance | Complies Complies | |
Appearance | White Crystalline powder | Complies | |
Particle Size | 50μm≤d(4.3)≤150μm D(0.9)≤350μm | Complies | |
Loss on Drying | ≤0.5% | 0.2% | |
Residue on Ignition | ≤0.1% | 0.07% | |
Specific Optical Rotation | +10.0°to -13.0° | +11.32° | |
Isopropyl alcohol | ≤5000ppm | 875ppm | |
Ethyl Acetate | ≤5000ppm | ND | |
Single Impurity | ≤0.5% | 0.17% | |
Total Impurity | ≤1.0% | 0.34% | |
Chlorides | ≤0.05% | Complies | |
Heavy Metals | |||
Total Heavy Metal | ≤10ppm | Complies | |
Conclusion | Conform with specification | ||
Storage | Store in cool and dry places. Keep away from strong light and heat | ||
Packing | By 25kgs/Drum, inner by double plastic bag | ||
Shelf Life | 24 months under the above condition, and in its original package | ||
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Production Flow
1. Raw material procurement:
Select high-quality starting materials to ensure the quality and purity of the resulting final product.
2. Activation reaction:
Through specific reactions, specific functional groups in raw materials are activated to create conditions for subsequent reactions.
3. Generation of intermediates:
In the different reaction steps, multiple intermediates are generated which are linked in subsequent steps and stepwise form the target compound.
4. Chain extension and transformation:
Through a series of reactions, the appropriate part of the molecule is extended and transformed, and the structure of the target molecule is gradually constructed.
5. Cyclization reaction:
Specific cyclization reactions are used to form the ring structure of the compound, which is crucial for formulating the core structure of the molecule.
6. Transformation of intermediates:
Intermediates are transformed in further steps, gradually approaching the structure of the target compound.
7. Salt formation:
For Pregabalin, by reaction with hydrochloric acid, the Pregabalin Hydrochloride salt is formed.
8. Purification and Purification:
After each key step, the product is purified by crystallization, distillation, chromatography, and other techniques to remove impurities.
9. Quality control:
During the production process, regular quality inspections are carried out to ensure the quality and structural integrity of the product.
10. Final isolation and packaging:
The final product is segregated and packaged under suitable conditions to prevent contamination and degradation.
Benefits
1. Neuromodulatory properties:
Raw Pregabalin Powder exerts a modulatory effect on the nervous system, exerting a positive influence on the neurotransmission process by affecting the release of neurotransmitters.
2. Chemical stability:
Its molecular structure endows it with chemical stability, helping to maintain high purity and activity during the pharmaceutical process.
3. Controllable bioavailability:
Its physical properties and solubility allow for controlled bioavailability in vivo, facilitating the adjustment of drug regimens.
4. Various formulation routes:
Its diversity and stability make it suitable for a variety of formulation routes, including oral, injection, and so on.
5. Potential application expansion:
In addition to the known uses, its properties open up the possibility of expanding its application in other fields.
6. Customizability:
Its chemical properties allow its further modification to meet the requirements of different formulations.
7. Controllable pharmacokinetics:
Its properties provide controllability for the study and application of pharmacokinetics and help optimize drug treatment regimens.
Application
1. Neuroscience research:
Because of its effects on the nervous system, Pure Pregabalin Powder is used in neuroscience research to explore neurotransmission mechanisms and therapeutic avenues for related diseases.
2. Drug development:
Its pharmacological properties make it an important link in the field of drug discovery for the design and synthesis of drugs with neuromodulatory properties.
3. Clinical practice:
Raw Pregabalin Powder is used as a drug raw material and used in clinical practice to provide treatment options for patients with neurological diseases.
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Manufacture
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