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Send InquiryMycophenolate Mofetil
Price 100 INR/ Kilograms
Mycophenolate Mofetil Specification
- Molecular Weight
- 433.50 g/mol
- Taste
- Bitter
- Color
- White to off-white
- Ph Level
- 4.56.5 (10% solution)
- Smell
- Odorless
- Storage
- Store at 2-8C, protected from light and moisture
- Heavy Metal (%)
- 0.001%
- Particle Size
- Micronized powder
- Melting Point
- 94-96C
- Loss on Drying
- 0.5%
- Structural Formula
- C23H31NO7 (structure as per IUPAC guidance)
- Poisonous
- YES
- Shelf Life
- 24 months
- Boiling point
- Not available (decomposes)
- Molecular Formula
- C23H31NO7
- Solubility
- Freely soluble in acetone, methanol, and ethyl acetate; practically insoluble in water
- HS Code
- 29349900
- Medicine Name
- Mycophenolate Mofetil
- Chemical Name
- Mycophenolate Mofetil
- CAS No
- 128794-94-5
- Type
- Other
- Grade
- Other
- Usage
- Immunosuppressive agent, organ transplant rejection prevention
- Purity(%)
- 99%
- Appearance
- White to off-white powder
- Physical Form
- Powder
- Standard
- USP/EP
- Microbial Limits
- Total aerobic microbial count 100 CFU/g
- Endotoxins
- <0.5 EU/mg
- Specific Optical Rotation
- +24 to +28 (c=1, methanol)
- Residual Solvents
- Complies with ICH guidelines
- Therapeutic Class
- Immunosuppressant
- Packaging
- HDPE Bottle or double PE bag in fiber drum, 1 kg/5 kg/10 kg
- Related Substances
- 0.2%
- Identification Tests
- By IR, HPLC
Mycophenolate Mofetil Trade Information
- Minimum Order Quantity
- 1 Kilograms
- Supply Ability
- 2000 Kilograms Per Day
- Delivery Time
- 1 Days
About Mycophenolate Mofetil
Mycophenolate Mofetil is also known as cellcept which becomes an active pharmacological agent by using mycophenolic acid which is an immuno-suppressant medication used to prevent rejection following organ transplantation of kidney, liver or heart and helps to protect them from any attack from immune system. Mycophenolate Mofetil can be used with other medications to weaken the defense system of body. It may lead to side effects such as constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, tremor, dizziness and drowsiness. Kindly contact your doctor if you suffer any serious bad effects like irregular heartbeat, easy bleeding, swelling of the feet and ankles.
Broad-Spectrum Immunosuppressive Efficacy
Mycophenolate Mofetil is widely recognized for its potent immunosuppressive properties, making it a preferred option in organ transplantation to prevent rejection. With high purity and stringent quality standards, it brings assurance to both healthcare providers and patients. Its reliable efficacy and safety, supported by global regulatory standards, facilitate its use across multiple therapeutic settings.
Unwavering Quality Standards & Compliance
Quality and safety are cornerstones of Mycophenolate Mofetil, verified through comprehensive testing: IR and HPLC identification, strict microbial and endotoxin limits, plus compliance with ICH guidelines for residual solvents. Manufactured according to USP/EP standards, it is packed securely in HDPE bottles or double PE bags within fiber drums, ensuring product stability and integrity throughout its shelf life.
FAQs of Mycophenolate Mofetil:
Q: How is the quality and purity of Mycophenolate Mofetil ensured during manufacturing?
A: Mycophenolate Mofetil undergoes rigorous identification tests using IR and HPLC methods to confirm its chemical identity and purity (99%). Related substances are controlled to 0.2%, and residual solvents comply with ICH guidelines. Microbial limits and endotoxin levels are also strictly enforced, in accordance with USP/EP standards.Q: What are the main therapeutic applications of Mycophenolate Mofetil?
A: This medicine serves primarily as an immunosuppressive agent, widely used for the prevention of organ transplant rejection. Its efficacy in suppressing the immune response helps lower the risk of graft loss, contributing to positive long-term transplant outcomes.Q: When should Mycophenolate Mofetil be stored, and under what conditions?
A: Mycophenolate Mofetil should be stored immediately upon receipt at a temperature range of 2-8C, protected from both light and moisture. Proper storage ensures that its potency and stability are maintained throughout its 24-month shelf life.Q: Where is Mycophenolate Mofetil produced and how is it packaged for distribution?
A: This product is manufactured in India and is available for distribution, export, import, and supply. It is packaged in HDPE bottles or double PE bags placed inside fiber drums, and offered in 1kg, 5kg, and 10kg quantities to suit varied requirements.Q: What is the process for identification and quality assurance for Mycophenolate Mofetil?
A: Each batch is verified through IR and HPLC testing to ensure it meets specified standards. Additional tests confirm limits for related substances, residual solvents, heavy metals (0.001%), microbial counts, and physical characteristics, securing both quality and compliance.Q: Is Mycophenolate Mofetil suitable for all patients?
A: Given its potent immunosuppressive effects and the fact that it is classified as poisonous, use is intended specifically for patients requiring organ transplant rejection prevention, under strict medical supervision. It should only be administered according to a doctors prescription.Q: What are the benefits of using Mycophenolate Mofetil in micronized powder form?
A: Micronized powder allows for better solubility and uniform distribution in various pharmaceutical preparations. This enhances bioavailability, ensures consistent dosing, and offers flexibility in formulation, benefiting both manufacturers and end-users.
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Contact Details
GST : 24AKEPV9396A1ZU
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