Controlled Substances
Critical APIs and intermediates with unstable pipelines and recurring shortage risk in North America, secured through
Sterile and pyrogen-controlled input materials used in injectable and liquid formulations with high regulatory scrutiny.
| Compound Name | Type | Primary Use | Handling Protocol | Documentation |
|---|---|---|---|---|
|
PEG 400 (Parenteral)
High-purity co-solvent
|
Compendial Co-Solvent | Injectable Solvent System |
Controlled storage
Validated cleaning
|
CoA
SDS
Endotoxin Statement
|
|
Propylene Glycol (Parenteral)
Injection-grade co-solvent
|
Compendial Co-Solvent | Solubility Support |
Low-endotoxin handling
|
CoA
SDS
USP/EP Alignment
|
|
Polysorbate 80 (Ultra-Pure)
Low peroxide / low endotoxin
|
Surfactant & Solubilizer | Injectable Stabilization |
Cold-chain optional
Product-specific profile
|
CoA
Peroxide Profile
Endotoxin Report
|
|
Trehalose Dihydrate
Sterile cryoprotectant
|
Tonicity & Stability Excipient | Biologic / mRNA Stabilization |
Moisture-controlled packaging
|
CoA
Endotoxin
Microbial Profile
|
Our Sterile Injectable Raw Materials range includes specialized, high-purity materials used in injectable, parenteral, and liquid pharmaceutical formulations. These materials are selected for applications where purity, endotoxin control, microbial quality, documentation, and consistent specifications are critical.
The category includes parenteral-grade co-solvents, surfactants, solubilizers, stabilizing excipients, and cryoprotective materials for pharmaceutical and biotechnology applications.