Capecitabine API

CAS:154361-50-9
Package: 1kg;25kg
Origin: China
Supply Ability: 10000kg per month
Sample Available: Yes
Shelf Life: Two years
Payment: T/T, LC or DA
Certifications: ISO9001, ISO22000, HACCP, HALAL, KOSHER
Third Party Test: available
Plant Audition: available
Can’t sell to individuals
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  • Quality Assurance
  • 24/7 Customer Service
Product Introduction

What is Capecitabine API?

Capecitabine powder is a prodrug that's precipitously converted into the active metabolite 5- fluorouracil( 5- FU) in the body by the action of multiple enzymes to ply its effect. Capecitabine API is a solid substance that exists as a white or nearly white crystalline powder.  The CAS number for it is 154361-50-9. It's slightly answerable in water and readily answerable in alcohol( ethanol).

The developmental history of it is as follows:

Early 1980s: It was first synthesized and subjected to initial pharmacological evaluation in research conducted by the pharmaceutical company Roche.

1997:Clinical trials of it commenced. During these trials, experimenters set up that it displayed similar efficacity to intravenous administration of 5- fluorouracil( 5- FU), but with advanced tolerability and a more accessible route of administration.1998: The U.S. Food and Drug Administration (FDA) approved the marketing of it.

Further exploration and advancements Over time, exploration on it has continued with the end of optimizing lozenge, treatment rules, and combination remedy strategies to enhance effectiveness and reduce side goods.

In summary, with further exploration and clinical practice, we can anticipate ongoing advancements and a deeper understanding of it and its operations.

Basic Information

Product name

Capecitabine

Chemical name

5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine

CAS

154361-50-9

MF

C15H22FN3O6

MW

359.35

EINECS

604-948-1

MDL No.

MFCD00930626

Purity

99%

Stability

Stable

Application

Medicine grade & Research grade.

Packing

As per your request

Storage

Room temp.

Structural formula

    154361-50-9.webp           

Quality standard

Test Items

Specifications

Result

Appearance

White to off-white crystalline powder.

Off-white crystalline powder

Solubility

Free soluble in methanol; soluble in Acetonitrile and in alcohol. Sparingly soluble in water.

Conforms

Identification

Infrated Absorption

Conforms


Retention time of the major peak in the chromatogram of assay corresponds to that in the chromatogram of the reference standard.

Conforms

Water Determination

≤0.3%

0.02%

Optical Rotation

+96.0° ~ +100.0°

+97.5°

Residue on Ignition

≤0.1%

0.01%

Heavy metals

≤20ppm

Conforms

Related substances

Capecitabine related compound A≤0.3%

ND


Capecitabine related compound B≤0.3%

0.03%


2,3-Di-O-acetyl-5′-deoxy-5-fluorocytidine≤0.10%

0.02%


5-Deoxy-5-fluoro-N4-(2-methyl-1-butyloxycarbonyl)cytidine + 5-Deoxy-5-fluoro-N4-(3-methyl-1-butyloxycarbonyl)cytidine

≤0.5%

ND


[1-[5-Deoxy-3-O-(5-deoxy-β-D- ribofuranosyl )-β-D- ribofuranosyl ]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]- carbamic acid pentyl ester≤0.3%

ND


[1-[5-Deoxy-2-O-(5-deoxy-β-D- ribofuranosyl )-β-D- ribofuranosyl ]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl ester≤0.2%

ND


Capecitabine related compound C≤0.3%

ND


[1-[5-Deoxy-2-O-(5-deoxy-β-D- ribofuranosyl )-α-D- ribofuranosyl ]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl ester≤0.3%

ND


2,3-Di-O-acetyl-5-deoxy-5-fluoro-N4-(pentyloxycarbonyl) cytidine≤0.1%

ND


Individual unspecified impurity≤0.1%

0.03%


Total impurities≤1.5%

0.10%

Assay

98.0%~102.0% on the anhydrous and solvent-free basis

99.9%

Conclusion: All the results conform to the requirement of USP

Packaging and storage:

Preserve in tight containers. Store at controlled room temperature.

Storage

The storage conditions for Capecitabine API are as follows:

Temperature: Store it at room temperature, typically recommended within the range of 15°C to 30°C (59°F to 86°F).

Packaging: Ensure it is stored in a dry and well-sealed container. Original packaging is the best choice as they are specifically designed to protect the stability of the medication.

Light protection: It is photosensitive and exposure to light can cause its degradation. Therefore, during storage, it should be kept in light-protected containers as much as possible to minimize the impact of light exposure.

Humidity: It is sensitive to humidity and can readily absorb moisture and undergo hydrolysis reactions. To avoid this, it should be stored in a dry environment and ensure the container is well-sealed.

Storage location: Keep it in a place away from humidity, heat sources, and harmful chemicals.

Please note that these storage recommendations are for general reference. Specific storage conditions may vary depending on the brand, manufacturer, or specific requirements of the medication.

Packing & Shipping

Customization:Customized logo;Customized packaging;Graphic customization

Shipping:

Item

Quantity

ETA time

Shipping Method

By Courier

≤50kg

7-15days

Fedex, DHL,UPS,TNT,EMS ect.

Fast and convenient

By Air

50kg~200kg

3-5days

Fast and cheap

By Sea

Large quantity

20-35days

Cheapest way

Payment Term

 payment.webp

Why Choose Xi'an Yihui?

Customer feedback

 Customer Comments.webp

Xi'an Yihui certificates

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Xi'an Yihui Factory & Warehouse

 00Factory & Warehouse.webp

Our Advantage

Rich experience: we have 13 Years of professional experience;

Customers all over the world: sell to more than 100 countries;

Provide diversified products: the products have been applied to all major international brands in the fields of drugs, dietary supplements, cosmetics, animal nutrition and functional food.

Price advance: low MOQ with competitive price;

Quality certification: ISO; Halal; Kosher certified

After-sales service: Professional team 7*24 hours customer service.

In conclusion

In summary, as a Capecitabine powder factory, we will provide customers with high-quality Capecitabine API and professional services.

if you need it, pls feel free to contact us any time. we will reply you asap.

Our contact information:

E-mail: sales@yihuipharm.com
Tel: 0086-29-89695240
WeChat or WhatsApp: 0086-17792415937

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