Паклитаксел на прах

Paclitaxel Powder – High-Purity API for Oncology & Medical Device Applications

Shaanxi Hongda Phytochemistry Co., Ltd. is a professional business that makes and sells high-purity Паклитаксел на прах (CAS: 33069-62-4). Their product has been tested by HPLC and found to be 99.0% pure. Our 20,000 m² plant has 100,000-level purification workshops and makes 3,000 tonnes of goods every year. It opened in 2001. We check each batch against USP/EP guidelines and look for impurities like 7-Epitaxol and Cephalomannine. You can trust our pharmaceutical-grade API, which has been approved by cGMP, ISO9001, ISO22000, HALAL, KOSHER, and other groups. Within 3–7 business days, we send it to buyers in North America, Europe, and Asia.

Продукт Въведение

A common chemotherapy drug is Паклитаксел на прах, a taxane diterpenoid. It inhibits cell division as an API. The molecules' formula is C₄₇H₅₁NO₁₄ and weigh 853.91 g/mol.

It was first found in Pacific yew tree bark (Taxus brevifolia), but presently it is usually synthesised from 10-Deacetylbaccatin III (10-DAB) from Taxus baccata needles and twigs. This strategy creates a reliable, scalable, and supply line.

The powder prevents microtubules from splitting when cells divide. This kills cancer cells. This white to off-white crystalline powder melts and breaks down around 213–216°C.

Доклад от тест на трета страна

Authorised third-party labs, such as SGS and Eurofins, check each batch of our API for the following issues:

Скрининг за остатъци от пестициди

Поглед към тежките метали

Тестване за микроби

GC method for residual solvent analysis

Certain optical rotation confirmation

You can get test results if you ask for them before you place an order.

Спецификации на продукта

Защо да изберете нас?

More than 20 years creating pharmaceutical-grade plant extracts since 2001.

20.000 m² GMP building with 100,000-level purification workshops.

Our annual output is 3,000 tonnes, ensuring us can fulfilll large demands.

The SGS-certified in-house lab has HPLC, GC, UV, and atomic absorption.

GMP, ISO9001, ISO22000, HALAL, KOSHER, FSSC22000, ORGANIC (EU & NOP), and others-certified.

Services that track temperature, delivery in 3–7 business days.

Help with COA, MSDS, third-party test results, and customs paperwork

Paclitaxel Powder Advantages

Чистота от фармацевтичен клас

Our item meets the requirements of both the USP and EP monographs, with an assay of 99.0% or higher by HPLC. For more complex formulas, there are premium grades that reach ≥99.5%.

Tough Control of Impurities

Impurities like 10-Deacetyltaxol (<0.5%), Baccatin III, and 7-Epitaxol are closely watched. Total impurities are limited to ≤1.0%, which means it can be used intravenously on people.

Compliance with Injectable-Grade Endotoxin

The LAL method is used to check for bacterial endotoxins and keep them below 0.4 EU/mg, which is the safest level for intravenous formulations.

Long-lasting Semi-Synthetic Source

Leaves of the Taxus baccata tree, not the wood, give it this smell. This makes sure that natural resources are safe and that there is a steady supply that can be expanded.

You can change the particle size

To coat a drug balloon (DCB), there are different micronised grades with different particle size distributions (PSDs). It's easy for the covering to move through tissue because of its microcrystalline shape.

Paclitaxel Powder Application

1. Injectable Chemotherapy (Oncology)

Taxol® and its generics work because of this API. It helps people with Kaposi's sarcoma, ovarian cancer, breast cancer, and lung cancer. For fewer hypersensitivity reactions, it can be made with Cremophor EL or Polyoxyl 35 Castor Oil and albumin-bound nanoparticles.

2. Stents that release drugs and balloons that are coated with drugs

It sticks well to device surfaces and moves quickly into vessel walls because it is lipophilic. This stops neointimal hypertrophy and makes restenosis less likely. There are different grades of crystalline morphology for even coating.

3. New Systems for Delivering Drugs

The powder is used by scientists to create liposomes, hydrogels, and micelles made of many tiny parts. The Enhanced Permeability and Retention (EPR) effect lets it get straight to tumours because it doesn't mix with water.

OEM / ODM поддръжка

People can ask for specifics that aren't available on the website, like different particle sizes, a certain crystalline form (anhydrous vs. dihydrate), or different ways to package the goods. Together with your recipe team, our R&D team of more than 20 experts comes up with new recipes.

Large amounts of powder, small packs that have already been weighed, and paperwork packages that meet the needs of your regulatory filing (DMF, ASMF) can all be used. You can get samples starting at 20g before you decide to place a full order.

Производствен процес

Our production follows a strict semi-synthetic road in cGMP-approved conditions:

1. Getting the raw materials: Taxus baccata seeds from farms that are closely watched

2. The extraction of 10-DAB: standardised solvent extraction with control of residual solvent

Three. Semi-Synthesis: controlled chemical change to Paclitaxel in a clean room

4. Purification: chromatographic purification with multiple steps to get ≥99.0% purity

5. Drying and milling: low-temperature methods to keep the crystal structure

6. QC tests—Full HPLC, GC, Karl Fischer, LAL, and optical rotation tests done in-house

7. Опаковка: 25 kg of double-layer PE bags in fibre drums in a 100,000-level dust-free workshop

Нашата фабрика - Sanxin

Сертификати

Често задавани въпроси

Q1: Is your product natural or partly synthetic?

A: It is partly manufactured and comes from 10-DAB that was taken from the needles of Taxus baccata. This makes sure that there is a steady supply and that the quality stays high.

Q2: What tests does your product pass?

A: It meets the current monographs from both the USP and the EP, which include limits for impurities in Cephalomannine and 7-Epitaxol.

Q3: How should I keep it?

A: Keep it at 20–25°C in containers that don't let light in. Photosensitive and hygroscopic, the powder needs to be kept dry while it is being stored.

Q4: Do you have micronised grades that can be used in DCB applications?

A: Yes. For drug-coated balloon coating processes, we have micronised grades with controlled PSD that come in both dihydrate and anhydrous crystal forms.

Q5: What is the smallest amount I can order?

A: Samples starting at 20g can be looked at. For information on MOQ for business orders, please Свържете се с нас директно.

Q6: What do you do with solvents that are left over?

A: Every run of GC tests shows that the solvents used in extraction and purification, such as methanol, acetone, and tetrahydrofuran, are within the limits set by ICH Q3C.

Свържете се с нас

Ready to source pharmaceutical-grade taxane API with Паклитаксел на прахИзпратете запитването си до duke@hongdaherb.com and receive a COA and quote within 24 hours.