GMP FDA API Pimecrolimus Raw Material Powder with CAS 137071-32-0

• Customization: Available
• CAS No.: 137071-32-0
• Shelf Life: 3 Years
• Model NO.: APIs
• Grade: Pharmaceutical Grade
• Transport Package: Carton
• Origin: China
• Production Capacity: 150000000 Ton

Product Description

GMP FDA Pharmaceutical Chemicals Pimecrolimus Raw Material Powder with CAS 137071-32-0

 

Product Details

 

Description

 

Certificate  of  Analysis
Product Name: Pimecrolimus
CAS No.: 137071-32-0

Batch No.	HF180320	Quantity	30kgs
Mfg. Date	Mar. 20, 2018	Package	As required
Rep. Date	Mar. 24, 2018	Exp. Date	Apr. 19, 2019
Items	Standards		Results
Appearance	White or off-white powder		Complies
Identification	By IR		Complies
	By HPLC		Complies
Specific Optical Rotation	-105.0°~-110.0°		-107.6°
Water Content	≤ 2.00%		0.60%
Heavy Metals	≤ 20ppm		Complies
Residual on Ignition	≤ 0.10%		0.06%
Residual Solvents	Acetonitrile ≤410ppm		ND
	Acetone ≤5000ppm		615ppm
	Methanol ≤3000ppm		ND
	Dichloromethane ≤600ppm		ND
	n-Heptane ≤5000ppm		1271ppm
Related Substances	Impurity A: ≤0.50%		ND
	Impurity D: ≤0.50%		0.24%
	Impurity C: ≤0.15%		ND
	Impurity D: ≤0.50%		0.15%
	Each of Unspecified impurity: ≤0.10%		0.04%
	Total Impurities: ≤1.00%		0.44%
Assay (HPLC basis on drying)	98.0%~102.0%		99.20%
Microbial Limit	Total Aerobic: ≤100cfu/g		<10cfu/g
	Total Yeasts and Molds: ≤100cfu/g		<10cfu/g
	Staphylococcus Aureus: Absent		Absent
	Pseudomonas Aeruginosa: Absent		Absent
PSD	D50: ≤ 40µm		12.65µm
	D90: ≤ 100µm		42.80µm
Reference Standard	In-house Standard
Conclusion	The product complied to In-house standard.
Storage	Preserve in tight,light-resistant containers in a cool place,at temperature 2ºC~8ºC

 

 

 

 

 

 

Introduction

 

 

our company 


 Hebei xianri biotechnology co.,ltd mainly focusing on dietary supplements processing in China, providing wide range of natural products with different forms including softgel, tablet, Capsules, vegetables hard capsules, powder and gummy. our R&D department providing value-added OEM and private label services for you.

Our company covers an area of 8 hectares and we have over 600 workers and staff members ,we owns five dietary supplement processing factories and two marine raw material extracting factories , which have passed the quality management certifications of GMP cGMP,HACCP,U.S.FDA,ISO9001,ISO14001,OHASAS18001 and BRC for global retails. We have imported 18 large soft gel production lines and more than 20 pieces of production equipment, such as fully automatic tablet compressing machines, hard capsule filling machines,3D mixers and coating machines, our daily production capacity of 20 million pieces of nutritional supplements and more than 1200 health products , bottling capability of 150 thousand bottles. We are largest production base of dietary supplements in Asia.

FAQ
How to contact us:
 
 
 
Address: No.392 Huaibei Road,Yuhua Districe, Shijiazhuang,China.
Our Payment Terms: 
Payment terms: 30% TT in advance as deposit for us to start the production, and the balance should be
TT after the shipment and before the seller release the Original B/L to buyer. 

Q: When can I get the price?
A: We usually quote within 24 hours after we get your inquiry.
If you are very urgent to get the price, please tell us so that we will regard your inquiry priority.
Q: How can I get a sample to check your quality?
A: After price confirmation, we are happy for sending samples in 2 days to you once you need.
Q: What about the lead time for mass production?
A: Honestly, it depends on the order quantity and the season you place the order. Always 1 month.
Q: What is your terms?
A: W accept EXW, FOB, CFR, CIF, DDU, DDP, etc. You can choose the one which is the most
convenient or cost effective for you.


To get more information, just feel free to contact with us. 
Sincerely looking forward to your cooperation.