p-Synephrine Pharmaceutical Grade

p-Synephrine Pharmaceutical Grade – Premium Citrus Extract for Advanced Applications 

If you want the best plant extract, Kang Biotech's p-Synephrine Pharmaceutical Grade is it. Based on an HPLC study, this premium ingredient is 98% pure. It is made in our 33,000 m² plant, which has over 11 years of experience in specialized production. Our 30-million-square-meter bitter orange plantations are at the start of our integrated supply chain. This way, we can fully track our products from the time they are grown to the time they are sold. There is no m-synephrine or o-synephrine contamination because each batch goes thru strict isomer differentiation tests to make sure it is the pure p-isomer (CAS No: 94-07-5). Our pharmaceutical-grade material is certified by ISO 22000, HACCP, Halal, and Kosher, which means it meets strict international standards for use in diabetes, lung medicine, and clinical nutrition.

Technical Specifications

Why Choose Our p-Synephrine Pharmaceutical Grade ?

Purity and Isomer Control

Unlike most plant extracts, ours is tested using chiral HPLC to make sure it only has p-isomer content. This gets rid of the heart risks that come with synthetic racemic mixtures. Your products work better when the bioactivity is stable and there is no unwanted isomer influence.

Complete assurance of quality

As part of our quality control process, we test for heavy metals using ICP-MS, look at leftover solvents using GC-HS, and find out how much ash is in the product. Each proof of analysis shows that the method used is in line with USP/EP standards. You get information that is checked by foreign regulators the first time.

Advantages of Vertical Integration

We are in charge of the whole process, from growing our own bitter orange trees to using advanced water and ethanol extraction methods to finely grind the oranges. This vertical integration makes consistency between batches possible that can't be found with third-party suppliers. It becomes easier to plan your product stability tests.

Core Applications in High-Performance Markets

Formulations for regulating metabolism and weight

Pharmaceutical-grade p-Synephrine is used in weight control drugs as a specific alpha-1 adrenergic agonist. It speeds up thermogenesis and lipolysis while keeping cardiovascular safety in check. When used in the right amounts, your products burn fat without raising blood pressure or heart rate.

Solutions for Respiratory Medicine

It is useful in over-the-counter decongestants and bronchodilation products because it can lessen mucosal swelling. It works well in complicated pulmonary environments where accurate dosing is very important. Your respiratory formulations get an active ingredient from plants that has been shown to work.

Elite Nutrition for Sports

To meet strict performance standards, pharmaceutical-grade ingredients are needed in clinical-range sports supplements. When mixed with caffeine anhydrous or acidic media, our material stays solid. It improves the way fat is burned during physical activity while still following safety rules for athletes.

Compatibility with Multiple Ingredients

It can be used in tablets, capsules, and even pressurized metered-dose inhalers because it is very stable at high temperatures (melting point 187–189°C). Our micronized version has a particle size distribution (D90 <10μm) that works with methods that deliver drugs to the lungs. Your R&D team gets formulation freedom across different types of transportation.

Advanced Quality Control Protocol

Multiple Levels of Analytical Testing

For p-Synephrine Pharmaceutical Grade, our quality control starts with HPLC tests that show a minimum concentration of 98%. After that, we use ICP-MS to make sure that heavy metal levels stay well below 0.1 ppm. GC-HS analysis of residual solvents confirms that the product meets ICH guidelines for pharmaceutical uses.

Microbiology and Verification of Stability

Microbiology tests are done on each lot to look for E. coli, Salmonella, and total plate count. We test for rapid stability at 40°C/75% RH to make sure that the product will last at least 24 months. With our recorded security data, you can be sure that your supply chain planning is correct.

Help with Regulatory Documentation

Our Joint Research Center with the Hunan Institute of Agricultural Product Processing helps with regulatory filings with expert support. We provide Drug Master Files (DMF) and licenses that make it easier to clear customs around the world. You cut down on the time it takes to get a foreign product on the market.

Flexible Manufacturing and Custom Solutions

OEM and ODM Services

We offer custom specifications, such as changing the purity, changing the particle size, and providing special packaging. Our 9 advanced production lines can handle orders of any size, from 1 kg samples for initial testing to bulk orders of over 1000 kg. Technical help is given to meet your specific recipe needs.

Several Delivery Choices

When you have ready stock, you can quickly send samples via FedEx, air freight for medium volumes, or sea transportation for bulk shipments at a low cost. Our operations team organizes the paperwork for customs so that clearance doesn't take too long. You keep your inventory flexible without having too much on hand.

Services for Technical Advice

Our team has been extracting citrus fruits for more than 20 years and can help you with your  manufacturing problems. We help with improving solubility, giving advice on pH stability, and checking for excipient compatibility. With expert insights, you can speed up the development of products.

FAQ

Q1: What is the difference between p-Synephrine and ephedrine in terms of safety?

A: At normal doses, p-synephrine doesn't bind very strongly to beta-1 and beta-2 adrenergic receptors. This gives it warming benefits without the heart-racing effects of ephedrine. This makes it much safer for long-term use in controlled markets.

Q2: How do you make sure that manmade isomer pollution is not present?

A: We use chiral HPLC columns that are made to sort and measure p-, m-, and o-synephrine isomers. This analysis is included in the certificate of analysis for every production batch. This keeps the purity of the pharmaceuticals throughout the supply chain.

Q3: Is this substance stable when mixed with liquids?

As long as the pH level stays between 3.5 and 5.5, the product will stay stable. For long-term stability, we suggest slightly acidic surroundings and amber glass cases for water-based solutions. Our technical team can give you stability protocols that are specific to your formulation.

Q4: What governmental paperwork backs up the use of drugs across borders?

A: Our work is backed by Drug Master Files (DMF) and meets the needs of both USP and EP monographs. We offer full regulatory support packages that meet the requirements of the FDA, EMA, and CFDA. These packages include heavy metal test results, residue solvent analyzes, and microbiology certificates.

Q5: Can this grade be used in devices that inhale under pressure?

A: Of course. Our pharmaceutical grade micronized material is tested for particle size distribution, and the D90 values are usually less than 10 µm. This standard makes sure that it can be used with metered-dose inhalers and dry powder inhalation systems that need precise deposits in the lungs.

Packaging and Storage Recommendations

Standard packaging comes in 25 kg fiber drums with two food-safe plastic bags inside. For smaller operations, custom packaging options come in 1 kg, 5 kg, and 10 kg sizes.

Keep things in sealed containers out of direct sunlight and below 25°C. To keep the <1.0% moisture specification, the relative humidity shouldn't go above 60%. When kept in these settings, the material stays pharmaceutically sound for more than 24 months.

Contact Us

Ready to elevate your formulation with p-Synephrine Pharmaceutical Grade? Contact our technical team at sales02@kangbiotech.com for detailed certificates of analysis, stability data, and complimentary sample evaluation.