APIs

Professional APIs Manufacturers!

 

Zhengzhou Yuanli Biological Technology Co., Ltd. Founded in 2009, it focuses on the technological development and achievement transformation of chemical APIs, new materials and new drugs. It's the supplier of BNCT treatment products. The company is also a leading research and development institution and product supplier of Nitrogen heterocyclic (Acridine) series and Boron cluster (Carborane) series.

 
 
Why Choose Us

 

Our Factory
The R&D center is over 4,500㎡in Zhengzhou High tech Zone, and has a pilot plant, industrial transformation, and production base of over 80,000㎡in Sanmenxia Chemical Industry Park.

 

Quality Control
Our state-of-the-art facilities ensure compliance with regulatory standards, providing clients with reliable and efficient sourcing solutions. We manufacture your active pharmaceutical ingredients in compliance with the highest quality and safety standards.

 

Our Certificate
We provide products cooperation for customers in over 70 countries and have products or technology collaborations with over 80 universities or research institutions. Currently, 67 invention patents have been applied and 35 have been authorized. It's a National High-tech Enterprise company and also gets so many other certificates of provincial and city level.

APIs Overview

 

 

APIs stands for active pharmaceutical ingredient, meaning that it's the active ingredient in a finished drug. An API is what produces the intended effects of a drug. This means that APIs are one of two main components in drugs, the other half being the excipients, chemically inactive substances that deliver the effect of API.

Types of APIs

We offer the following Product

Top Grade L-Ornithine 2-oxoglutarate

L-Ornithine 2-oxoglutarate C10H18N2O7, CAS: 5144-42-3 , is white to off-white crystalline powder. L-Ornithine 2-oxoglutarate is mainly used in the pharmaceutical field. It can promote muscle growth and improve exercise, accelerate the growth of children with growth hormone deficiency, and enhance the immunity of trauma patients. It can also be used as a supplement for human physical enhancement.

Top Grade Inosine Powder, Hypoxanthine

Inosine, also known as hypoxanthine nucleoside or hypoxanthine nucleoside, is a nucleoside compound formed by the binding of hypoxanthine to ribose. Mainly used in the pharmaceutical field, mainly for the production of inosine tablets. Inosine tablets generally have the effect and efficacy of improving liver function.

Top Grade L-Ornithine 2-oxoglutarate, 5144-42-3,C10H18N2O7
CAS:58-63-9,top Grade Inosine Powder, Hypoxanthine

Good Quality Albendazole

Albendazole is white or almost white powder, odorless. It is used for making Abendazole tablets. Abendazole tablets are a broad-spectrum deworming medication mainly used to treat hookworm disease, roundworm disease, whipworm disease, pinworm disease, and trichinosis, and can also be used to treat cysticercosis and echinococcosis.

Top Grade Acyclovir

Acyclovir is used for antiviral drug. Acyclovir mainly has a good inhibitory effect on herpes virus, and studies have shown that it has a certain inhibitory effect on herpes simplex virus, varicella zoster virus, and cytomegalovirus.

Craftsmanship of APIs

 

 

APIs are manufactured from their raw materials, meaning several chemical compounds go through a process called intermediate before becoming an API. The process of API manufacturing typically involves several steps, including chemical synthesis, purification, and isolation. The specific steps involved in API manufacturing can vary depending on the type of compound being produced.

 

Some common methods used for manufacturing APIs include recombinant production, chemical synthesis or isolation from natural sources.

 

Once the API has been produced, it can be formulated into a final product, such as a tablet or capsule, for use by patients. Rigorous quality checks are carried out before being released to the general public.

 

Product Specification

We offer the following Product specifications:

Test Items

Requirements

Results

Appearance

White to off white crystalline powder

Complies

Assay

≥99.0%

99.8%

Loss on drying

≤1.0%

0.5%

Residue on ignition

≤0.1%

0.01%

Mesh

80% On 30 mesh

Conforms

Heavy Metals

≤10ppm

<10ppm

Arsenic

≤0.1ppm

<0.1ppm

Lead

≤3.0ppm

<3.0ppm

Cadmium

≤0.1ppm

<0.1ppm

Mercury

≤0.1ppm

<0.1ppm

Coliforms

Negative

Negative

Salmonella

Negative

Negative

Total plate count(cfu/g)

≤1000cfu/g

Conforms

Yeast&mold

≤50cfu/g

Conforms

 

Lnosine Powder, Hypoxanthine

Appearance

White crystals or crystalline powder; Odorless; Slightly bitter taste

Complies

Identification

1.Positive reaction

1. Complies

2.Positive reaction

2. Complies

3.Retention time complies to standard

3. Complies

4.Infrared absorption

4. Complies

Loss on drying

≤1.0%

0.4%

Residue on ignition

≤0.2%

Complies

Heavy Metals

≤10ppm

Complies

Assay

98-102%

99.5%

 

 

Good Quality Albendazole

Appearance

White or almost white powder, odorless

Almost white powder, odorless

Solubility

Slightly soluble in acetone and in chloroform, practically insoluble in ethanol, insoluble in water, soluble in glacial acetic acid.

Complies

Melting point

Should be 206~212℃

209.4℃ melting and decomposition, complies

Absorprtion coefficient

productcate-51-34Should be 430~458

productcate-51-34Should be 430~458

443.0

Identification1

Positive

Positive

Identification2

Positive

Positive

UV

Exhibit with maximum absorption at 295 ±2nm, and minimum absorption at 277± 2nm

Exhibit with maximum absorption at 295nm, and minimum absorption at 277nm

IR

Concordant with reference spectrum

Complies

Related Compounds

If impurity spot obtained with testing solution is visible, not more intense than the principal spot abtained with reference solution(1)

Complies

Loss on drying

≤0.5%

0.14%

Residue on ignition

≤ 0.2%

0.13%

Iron

≤ 0.0030%

Complies

Assay

It contains not less than 98.5% of C12H15N3O2S

99.16%

Particle size

90% ≤ 20 Microns

Complies

 

Uses of APIs

 

 

Active Pharmaceutical Ingredient (API): The core component that delivers the medicinal benefits.

Excipients: Inactive substances that act as carriers for the API, helping in the drug's stability, absorption, and taste.
●For example:
In paracetamol tablets, paracetamol is the API that reduces fever and relieves pain.
Other components like starch or magnesium stearate are excipients that aid in tablet formation

 

Other Services

 

Packing
The goods is packaged in cardboard drums, inside double layer polyethylene bags, 25kg/Drum, also can be packaged according to customer requirements.

 
 

Handling and Transportation
Packaging is suitable for all modes of transportation such as express delivery, airplane, sea freight, etc.

 
 

Storage
The goods should be stored in a cool, dry, and well ventilated place, sealed. Storage conditions should preferably be a sheltered environment with limited temperature variations and low humidity levels.Touch the package with water or any other liquid directly will cause the product to cake, should be stacked in pallets. Under normal conditions,the use of this product does not cause any undue health hazard. Precautions must be taken to prevent solid or liquid product to contact with skin or eyes.

 
 

Certification

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FAQ

Q: What Are Active Pharmaceutical Ingredients (APIs)?

A: APIs are the biologically active components in medicines responsible for the therapeutic effect. For instance, in a painkiller like ibuprofen, ibuprofen itself is the API that alleviates pain. While medications may contain other substances, such as fillers or stabilizers, the API is the core element that targets the medical condition.

Q: How Are APIs Manufactured?

A: APIs are typically produced through chemical synthesis, fermentation, or biotechnology processes. Here are the primary steps involved:
Chemical Synthesis: A step-by-step process combining different chemicals under controlled conditions.
Fermentation: Involves the use of microorganisms to produce complex molecules.
Biotechnology: Employs genetic engineering and biological systems to develop APIs.

Q: What Is the Difference Between API and Excipients?

A: In a drug, the API is the active ingredient, while excipients are inactive substances that serve as carriers or support the drug's delivery. Excipients help:
Enhance drug stability.
Facilitate absorption in the body.
Provide the desired form, such as tablets or capsules.
For example, in a tablet containing paracetamol as the API, the other ingredients like starch or magnesium stearate are excipients.

Q: Why Is API Quality Important?

A: The quality of APIs directly impacts the effectiveness, safety, and stability of medicines. Poor-quality APIs can lead to:
Reduced therapeutic effects.
Increased risk of side effects.
Contamination issues.

Q: What Are the Key Types of APIs?

A: APIs can be classified based on their sources or methods of production:
Synthetic APIs: Manufactured through chemical synthesis, commonly used in painkillers and antibiotics.
Biological APIs: Derived from living organisms, like insulin for diabetes treatment.
Natural APIs: Extracted from plants or animals, such as morphine from poppies.

We're well-known as one of the leading apis manufacturers and suppliers in China. Please feel free to buy high quality apis at competitive price from our factory. Contact us for more details.

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