99% Tacrolimus API Of GMP Factory

Introductions:

Tacrolimus monohydrate, also known as FK-506, is a white crystalline powder.

Existing as an anhydrous or monohydrate form, it is soluble in many solvents such as ethanol, methanol, acetone, and chloroform but insoluble in water.

It was first extracted as an antibiotic from soil actinomycetes in Japan in 1984.

Later, tacrolimus is found to be very effective in reducing the patient’s immune system activity and the risk of organ rejection after an organ transplant.

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Tacrolimus API Specifications

Tacrolimus Chemical Structure
Tacrolimus Chemical Structure

Product Name: Tacrolimus

Cas Number: 109581-93-3 For Monohydrate (104987-11-3 For Anhydrous)

Molecular Formula: C44H69NO12*H2O

Molecular Weight: 822.03 g/mol

Chemical Name: 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-, monohydrate

HS Code: 2934999090 ((Other heterocyclic compounds-其他杂环化合物))

Suitability to be shipped by air as common goods: suitable. It is safe to be shipped by air as common goods.

Grade: Pharma-Grade

Purity or Assay: 99%

Standards: Current USP Standards

Manufacturer Certificates available: GMP/CoPP/WC

Supplier Documents Available: COA/DMF/MSDS

Supply Capability: 50+ KG per Month

MOQ: 10 Grams

Price Ideas In 2023: 30~40 USD/G for 1KG, 50~60 USD/G for 100~500G, 110~150 USD/G for 1G~10G. (For more updated prices, contact us directly by email or WhatsApp)

Lead Time: 3~5 days for quantities less than 10KG, 3~4 days for orders less than 100 G.

Stock Status: Over 50 KG

Shipping Temperature: Room temperature

Storage: 2~8 °C

Technical Data:

Residue on ignition: NMT0.1%

Heavy metals: NMT10ppm

Specific optical rotation: -110 ~ -115°

Related substances: 

Ascomycin 19-Epimer: NMT0.1%, Ascomycin: NMT0.5%, Desmethyl Tacrolimus: NMT0.1%, Tacrolimus 8-epimer: NMT0.15%, Tacrolimus 8-propyl analog: NMT0.15%, Any individual unspecified impurity: NMT0.1%, Total impurities: NMT1.0%

Residual solvents: Ethanol: NMT0.5%, Acetone: NMT0.5%, Ethyl acetate: NMT0.5%, Isopropyl ether: NMT0.05%

Assay: 98.0%~102.0%

Why Choose Us As Your Tacrolimus API Supplier?

Are you still searching for a reliable tacrolimus API manufacturer in China?

Well, search no more! 

OCTAGONCHEM will be your perfect match if you are looking for a Tacrolimus supplier with top quality and competitive prices. Here is why you should select OCTAGONCHEM as your API partner in China.

#1. Unparalleled High Quality Through Optimal Manufacturing Process:

At OCTAGONCHEM we always take pride in our unwavering commitment to quality.

Our Tacrolimus API is produced in our GMP-Approved factory with our optimal manufacturing process, as you can see from our Certificate of Analysis the actual impurity value is 0. 

As our API is GMP-certified, it is suitable for medicine manufacturing after registration in your MOH and can be used for pharmacy compounding.

#2. Stable Supply By Fast Shipping and Timely Delivery:

As it is known to all, stable supply is very important for medicine manufacturing. By choosing OCTAGONCHEM as your Tacrolimus manufacturer in China, you are worry-free from supply issues.

To ensure our stable supply to our regular customers, we will keep a stock of around 25 KG so we can make prompt shipments right after we receive Purchasing Orders from our customers. 

Shipping by air requires a certificate of safe air transportation from DGM, we normally apply for each copy at the beginning of every year so goods can be shipped out within 3 days after order confirmation from our customers.

#3. NDC number/CoPP/WC Available For Smooth Import:

As our Tacrolimus API is registered in the USFDA with CoPP and Europe with WC, so It is suitable for compounding pharmacies within the USA, Canada, and Europe to import our API without any Customs issues.

If you are looking, please give us a chance to send you our offer and CoA for your approval. Your trust and reaching out to us will mean the world to us.

Manufacturer Documents Download

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