Oxytocin API CAS 50-56-6

Oxytocin API CAS 50-56-6 | Oxytocin acetate cGMP production | Obstetric first-line contractions API | Science-Peptide

Oxytocin API CAS 50-56-6 - a first-line peptide API for induction of labor, induction of labor and prevention of postpartum hemorrhage.Science-Peptide provides cGMP-compliant Oxytocin Acetate, with mature process, clear impurity profiles, support for Chinese, American and European declarations, and DMF authorization.Welcome to contact us.

Oxytocin's place in obstetrics is a bit like that of a basic infusion - not the most expensive, but definitely indispensable. Oxytocin is on the World Health Organization's list of essential medicines for inducing labor, inducing labor, and preventing postpartum hemorrhage, and is used globally in hundreds of millions of doses per year. We have been making peptide APIs for more than 20 years, and Hypocretin is one of the earliest varieties that we have started to make, and we have honed the process very thoroughly. To be frank, this peptide is not long and not difficult to synthesize, but to achieve a high degree of consistency between batches, stable impurity profiles, and to meet the pharmacopoeial standards of different markets, it relies on more than 10 years of experience.

 

At present, our Peptide Acetate API can be stably supplied from grams to hundred kilograms, has completed the FDA DMF filing, and supports China, the United States and Europe to declare. The impurity profile is clear, disulfide bond mismatch, oxidation products, missing peptides and other key impurities are all within the controllable range. If you are doing consistency evaluation or ANDA filing for the preparation of pycnogenol and need API, we can talk about it.

Oxytocin is a 9-peptide cyclized by a pair of disulfide bonds. It is a hormone secreted by the body itself and has a direct effect when administered exogenously: it binds to uterine smooth muscle receptors, causing calcium to flow in and out of the uterus, resulting in regular contractions. It also promotes the release of prostaglandins, making contractions stronger.

A few key clinical uses:

• Induction and induction of labor: In full-term pregnancies with preterm rupture of membranes or difficult initiation of labor, intravenous oxytocin is standard.
• Prevention of postpartum hemorrhage: When used immediately during the third stage of labor, it reduces the risk of postpartum hemorrhage by more than 40%. In less developed areas, it is even the only contraction agent available.
• Treatment of postpartum hemorrhage: After the onset of hemorrhage, oxytocin is given in combination with ergonovine and misoprostol.
• Promote milk evacuation: This is less commonly used, usually in nasal spray form.

From the point of view of APIs, the characteristics of the contractions are large volume, low price, and stable requirements. There are dozens of domestic preparation approvals and many international generic manufacturers. Customers choose suppliers based on three points: whether the batch consistency is good or not, whether the impurity profile is in line with the pharmacopoeia, and whether the supply will be interrupted. We have put a lot of effort into these three points.

1. The process has been running for more than a decade, and amplification is not a concern
The synthetic route of pycnogenol is very classic - solid phase as a linear precursor, liquid phase cyclization to form disulfide bonds. However, the classic route does not mean that there is no pitfalls. In the early years, we also encountered the problems of fluctuating cyclization efficiency and low purification yield, and then we optimized the process step by step, and now the process is very stable:
Linear precursor:Fmoc solid phase synthesis, each amino acid coupling is monitored.
Cyclization: Mild oxidation in liquid phase, stable cyclization efficiency above 95%, disulfide bond mismatch is controlled at a very low level.
Purification: Multi-step preparation by HPLC, cutting out missing peptides, oxidized impurities, dimers one by one.
Freeze-drying packaging: clean area operation, double-layer aseptic bag.
From a few grams of small trials to hundreds of kilograms of commercialized batches, we have been running for more than ten years. The process validation data shows that the impurity profiles of successive batches are highly overlapping, and the dissolution curves are consistent between batches when the customer takes them to make preparations.

2. Quality control is not an exercise
Each batch of Peptide API is released according to cGMP requirements, and the testing program is more detailed than the Pharmacopoeia:
Content:95.0%-105.0% as per anhydrous and solvent free, in accordance with USP standard.
Purity: HPLC ≥99.0%, actual batch is usually 99.2%-99.5%.
Related substances: single impurity≤0.15%, total impurity≤1.0%.
Impurity profile: disulfide bond mismatch isomers, methionine sulfoxide (oxidized impurities), missing peptides, dimers, all with controls and quantification methods.
Safety indicators: endotoxin <0.25 EU/mg, microbiological limits in accordance with the Pharmacopoeia, residual solvents in accordance with ICH Q3C.
The stability is long-term and accelerated, supporting a 24-36 month retest period. The methods are validated and comply with ICH Q2 and USP/EP requirements.

3. Fully documented and DMF filed
The pathway for the filing of the contractions is well established, and the information we have provided can be used directly:
Process development report (how key parameters were determined)
Process validation programs and reports (multi-batch data) analytical method validation reports
Stability data (long-term, accelerated, impact factors)
Heterogeneous mass spectrometry report (with structural confirmation)
Structural corroboration information (NMR, MS, IR)
Batch production records (complete and traceable)
In conjunction with on-site audits
Our Peptide API has completed the FDA DMF filing, can authorize customers to use in China, the United States and Europe declaration. If you need European CEP, we can also cooperate with you.

4. The supply chain is double-insured
Peptide is a well-established product, but we've seen it before when the supply of raw materials is cut off. So:
At least two qualified suppliers for key materials (amino acids, resins), with regular factory audits.
We keep a safety stock of materials with a long purchasing cycle, so that production will not be stopped due to shipping delays.
Multiple production lines can be scheduled in parallel, and rush orders can also be inserted into the queue.
As for the cooperation mode, we can sell APIs, authorize DMF, or transfer the technology to the customer's designated site. Packaging specifications can be customized according to the needs of the preparation, and we will cooperate with you.

• Manufacturing facility 10 acres, cGMP standard, FDA, EMA, NMPA compliant, ISO 9001:2015 certified.
• Synthesis plant: automated solid phase synthesis, 100 kg capacity
• Purification workshop: multiple sets of HPLC preparation, flow rate covering 50mL-1000mL/min
• Freeze-drying workshop: 30 square meters +, industrial freeze-drying machine
• Clean area: ISO class 7/8
• QC Lab: HPLC, UPLC, LC-MS, GC, ICP-MS, all of them
• In terms of quality system, change control, deviation management, CAPA, supplier audit, annual quality review are all routine operations. We have cooperated with FDA, EMA, NMPA on-site audits, and have a lot of experience.

Client A, a domestic pharmaceutical company: doing consistency evaluation of contraction injection, the impurity profile of the raw material used before was not stable. We provided three batches of raw materials for validation with a full set of impurity data, and they directly took them to make the preparation. Later, they passed the evaluation, and now they have been cooperating with us for more than three years with stable purchasing every month.

Client B, Southeast Asia pharmaceutical plant: local registration needs Pepto-Bismol API, which is required to meet EP standard. We have supplied five batches in a row, the purity of each batch is above 99.2%, and the impurity profile is consistent. They used our raw materials to make preparations, got the local registration approval, and now regular replenishment every year.

The product is a mature product, but the more mature it is, the more the supplier's basic skills are tested - whether the batch is stable or not, whether the impurities are complete or not, whether the documents can be used or not. We have been working on this species for more than ten years, and we think we have delivered a good answer. If you are doing the preparation of pycnogenol, need to find API suppliers, welcome to chat.