The Ultimate Guide to DOS Plasticizer in 2024 Wellt
- Classification:Chemical Auxiliary Agent
- CAS No.:2432-87-3, 2432-87-3
- Other Names:Dioctyl Sebacate / DOS
- MF:C26H5004, C26H5004
- EINECS No.:219-411-3
- Purity:99.50%, 99.50%
- Type:Plasticizers
- Usage:Coating Auxiliary Agents, Electronics Chemicals, Plastic Auxiliary Agents, Rubber Auxiliary Agents, Surfactants
- MOQ:1000KG
- Acid value(mgKOH/g)≤:0.02%
Volatility and Its Role in DOS Applications Manufacturers and Suppliers —— The Dioctyl Sebacate (DOS) industry is a global market with a variety of manufacturers and suppliers that cater to a wide array of needs. These companies offer an assortment of DOS products,
1. Excipient manufacturers and distributors, defined as suppliers in this document, 2. Medicinal (drug) product manufacturers, defined as users in this document, and 3. Public health and
Ensuring Product Stability Choosing the Right Excipients
- Classification:Chemical Auxiliary Agent, Chemical Auxiliary Agent
- CAS No.:2432-87-3
- Other Names:Dioctyl Sebacate / DOS
- MF:C26H5004, C26H5004
- EINECS No.:219-411-3
- Purity:99.5%
- Type:Plasticizers
- Usage:Coating Auxiliary Agents, Electronics Chemicals, Leather Auxiliary Agents, Paper Chemicals, Petroleum Additives, Plastic Auxiliary Agents, Rubber Auxiliary Agents, Textile Auxiliary Agents, Water Treatment Chemicals, Other
- MOQ:200kgs
- Acid value(mgKOH/g)≤:0.02%
The stability of pharmaceuticals is an important product quality attribute. Of the known factors affecting stability, moisture is often perceived as the most common cause of drug degradation
- the monitoring of the Quality Assurance procedures of suppliers of raw and packaging materials, with regular audits where possible; the development of a Supplier Quality Assurance
What is a Stability Study and why is it important? PQE Group
- Classification:Chemical Auxiliary Agent
- CAS No.:2432-87-3
- Other Names:SEBACIC ACID DI-N-OCTYL ESTER
- MF:C26H5004, C26H5004
- EINECS No.:219-411-3
- Purity:99.5%
- Type:Plasticizers, Plasticizer
- Usage:Coating Auxiliary Agents, Electronics Chemicals, Plastic Auxiliary Agents, Rubber Auxiliary Agents, Textile Auxiliary Agents
- MOQ:1000KG
- Product Name:DOS
Stability Studies. The term ‘Stability’ can be defined as the period of time in which a product remains stable under the recommended conditions (as different products require different
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle (Figure 1). Stability is part of a biotherapeutic’s quality target product
Considerations for Updates to ICH Q1 and Q5C Stability
- Classification:Chemical Auxiliary Agent, Chemical Auxiliary Agent
- CAS No.:2432-87-3
- Other Names:Dioctyl Sebacate / DOS
- MF:C26H5004, C26H5004
- EINECS No.:219-411-3
- Purity:99.5%
- Type:Plasticizers, Plasticizer
- Usage:Coating Auxiliary Agents, Electronics Chemicals, Plastic Auxiliary Agents, Rubber Auxiliary Agents, Textile Auxiliary Agents
- MOQ:1000KG
- Acid value(mgKOH/g)≤:0.02%
In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium
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ESC Electronic Stability Control System
- Classification:Chemical Auxiliary Agent
- CAS No.:2432-87-3
- Other Names:DOS
- MF:C26H50O4
- EINECS No.:219-411-3
- Purity:99% min, ≥99%
- Type:Adsorbent
- Usage:Coating Auxiliary Agents, Electronics Chemicals, Leather Auxiliary Agents, Paper Chemicals, Petroleum Additives, Plastic Auxiliary Agents, Rubber Auxiliary Agents, Surfactants, Textile Auxiliary Agents, Water Treatment Chemicals
- MOQ:200kgs
- Color:Colorless transparent
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- What is a stable product?
- The term ‘Stability’ can be defined as the period of time in which a product remains stable under the recommended conditions (as different products require different conditions), without compromising its integrity. This means that no physical or chemical changes occur, and the product retains the same quality as when it left the manufacturer.
- When do I need to submit a “in use” stability data?
- Where the product is to be diluted or reconstituted before being administered to the patient (e.g. a powder for injection or a concentrate for oral suspension), “in use” stability data must be submitted to support the recommended storage time and conditions for those dosage forms.
- Why is the stability of pharmaceuticals important?
- The stability of pharmaceuticals is an important product quality attribute. Of the known factors affecting stability, moisture is often perceived as the most common cause of drug degradation by hydrolysis or other reactions facilitated by moisture as a medium.
- How many batches are selected for the stability study?
- During the first year of manufacture, three initial batches are selected for the Stability Study. The following years, one batch, per strength, per year is selected to be put on stability. This is done to monitor ongoing quality and ensure that while the product is still on the market, it remains within specification.
- What is a stability guideline?
- The guideline is intended to provide excipient manufacturers with strategies for assessment of overall stability as well as provide an approach for a manufacturer to establish a stability study program which includes study design.
- Should stability data be available?
- Stability information which may include stability data should be available. However, stability data is sometimes proprietary (e.g., compositional details) and under such circumstances sharing the data with users may be handled under confidentiality agreements, to protect the manufacturer’s intellectual property.
