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Isotretinoin Powder
2.Specification:99%
3.CAS：4759-48-2
4.Free Sample
5.Capsules,tablets,softgel,gummies,small bags,private label
6.Test Method:HPL,UV&GC
7.Vacuum Aluminum Foil Bag; Fiber Drum for 25kg with inside double layer food grade poly bag
8.DeliveryTime:1-3 working days
Organic,Gluten free,no Allergen,Non-GMO,Paraben free,No Colors, BSE/TESE Free,Vegan
- Product Description
Isotretinoin Powder Manufacturer and Supplier
Shaanxi Fairir Biotech Co., Ltd. is a leading manufacturer and supplier of premium Isotretinoin Powder. Our state-of-the-art facilities and rigorous quality control processes ensure that we deliver the highest quality Active Pharmaceutical Ingredient (API) for acne treatments. With our advanced extraction technologies and GMP-certified production plant, we offer unparalleled purity and potency in our product.
What is Isotretinoin Powder?
The product is a potent retinoid compound used in the treatment of severe acne. It's the active ingredient in many prescription acne medications, known for its effectiveness in reducing sebum production and preventing clogged pores.
Why Choose Us?
- ISO, USDA Organic, EU, and Halal certifications
- Advanced CO₂ supercritical extraction technology
- 10,000㎡ GMP-certified production facility
- Comprehensive quality management system
- Customized manufacturing capabilities
COA (Certificate of Analysis)
|
Items |
Specifications |
Results |
|
Description |
Orange crystalline powder |
Complies |
|
Identification
|
The IR absorption spectrum should correspond with reference spectrum |
Complies |
|
Should exhibits maximum absorption at 354nm |
Complies |
|
|
Loss on drying |
≤0.5% |
0.09% |
|
Residue on ignition |
≤0.1% |
0.02% |
|
Heavy metals |
≤ 0.002% |
＜0.002% |
|
Organic volatile impurity
|
≤3000 ppm |
380ppm |
|
Ethyl acetate ≤ 5000 ppm |
120ppm |
|
|
Isopropanol ≤ 5000 ppm |
130 ppm |
|
|
Tretinoin |
≤1.0% |
0.07% |
|
Assay (anhydrous) |
98.0%-102.0% ( Calculated on the dried basis) |
99.7% |
|
Storage Shelf Life |
Store in a well-closed containers,in a cool dry area. Two years if sealed and stored away from direct sun light and heat. |
|
|
Conclusion |
The product complies with USP40. |
|
*Please contact us for the lastest COA.
Isotretinoin Powder Function
The product functions as a powerful acne treatment by:
- Reducing sebum production
- Preventing clogged pores
- Decreasing inflammation
- Inhibiting bacterial growth
Our Manufacturing Process
At Shaanxi Fairir Biotech, we employ cutting-edge extraction technologies to produce high-quality product. Our solvent-free CO₂ supercritical extraction method ensures superior bioactivity retention compared to conventional methods. Our GMP-certified facility houses 23 stainless steel extraction tanks and three fully automated production lines, achieving 98% efficiency.
Benefits for Global Buyers
- Consistent High Quality: Our stringent quality control measures ensure product consistency.
- Regulatory Compliance: We meet international standards, simplifying your approval processes.
- Competitive Pricing: Our efficient production allows for attractive bulk pricing.
- Flexible Packaging: We offer customized packaging solutions to meet your specific needs.
- Technical Support: Our expert team provides comprehensive support for your formulation needs.
- Fast Turnaround: Our large-scale production capacity ensures quick order fulfillment.
- Supply Chain Reliability: We maintain consistent availability and offer fast lead times.
- Comprehensive Documentation: We provide detailed COA, MSDS, and regulatory support.
Isotretinoin Powder Applications
Isotretinoin Powder is primarily used in the pharmaceutical industry for manufacturing acne treatments. It's also utilized in dermatological research and the development of novel drug delivery systems. Our high-purity powder is suitable for various formulations, including oral capsules, topical gels, and innovative dosage forms.
Quality Assurance
Our comprehensive quality management system covers the entire production chain, from raw material sourcing to finished product testing. We employ advanced analytical equipment, including HPLC and GC systems, to ensure the highest quality standards.
Certification
We hold multiple international certifications, including:
- GMP (cGMP)
- ISO 9001
- ISO 22000
- HACCP
- FSSC 22000
- Kosher
- Halal
OEM/ODM Services
We offer contract manufacturing services.
Packaging and Delivery
Our product is packaged in sealed, light-resistant containers to maintain its potency. We offer various package sizes to suit your needs and ensure safe, timely delivery worldwide.
FAQ
Q: What is the minimum order quantity for the product?
A: Our MOQ is 1 kg, but we can discuss smaller quantities for sample orders.
Q: Can you provide stability data for your product?
A: Yes, we offer comprehensive stability data upon request.
Q: Is your product suitable for topical formulations?
A: Yes, our high-purity powder is suitable for both oral and topical formulations.
Q: What is the lead time for bulk orders?
A: Typical lead time is 2-3 weeks, depending on order volume.
Q: Do you offer micronized product?
A: Yes, we can provide micronized powder upon request.
Q: Can you assist with regulatory documentation for our market?
A: Absolutely, our regulatory team can provide necessary documentation support.
Contact Us
For inquiries about our Isotretinoin Powder or other products, please contact us at sales@fairirbiotech.com. Our team is ready to assist you with any questions or customized requirements.
