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Zhejiang Honor Biotechnology Co., Ltd.
Email: zhaoqiang.peng@rongyaobiotech.com
Address: No. 30, Duchuan South Road, Linhai Industrial Park, Zhejiang Province Chemical API Base
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What do pharmaceutical starting materials include?
Release time: 2026/03/30
Starting material is a chemical substance used in the chemical synthesis of active pharmaceutical ingredients and incorporated as an essential structural moiety into the final drug molecule. It is typically introduced early in the synthetic process and serves as the starting point for API registration submissions and quality control.
According to ICH Q11 and the regulatory requirements of various countries, pharmaceutical starting materials primarily fall into the following categories:
Commercially available chemical reagents
Compounds with a well-defined chemical structure that are commercially available, such as specific aromatic amines and halogenated hydrocarbons, provided that their structure significantly contributes to the core scaffold of the active pharmaceutical ingredient.
Intermediates manufactured in-house or under contract
Substances that are not commercially available but have a well-defined structure, controllable quality, and are either synthesized in-house by the manufacturer or produced on a custom basis through contract manufacturing. For such materials, complete information on the preparation process and quality control measures must be provided.
Nucleoside building blocks (for oligonucleotide drugs)
Compounds such as nucleoside phosphoramidites, modified nucleoside monomers, and pre-loaded solid-phase supports serve as critical starting points for the synthesis of nucleic acid-based therapeutics, including siRNA and antisense oligonucleotides.
Active precursors in naturally sourced extracts
For semi-synthetic active pharmaceutical ingredients (such as antibiotics and hormonal drugs), the starting materials may be naturally occurring compounds with specific structures that are extracted from animal, plant, or microbial fermentation products; for example, potassium penicillin G serves as the starting material for semisynthetic penicillins.
Key chiral intermediates or metal complexes
In the synthesis of complex molecules, certain high-purity chiral compounds or catalyst complexes may also be accepted as starting materials to ensure stereochemical consistency, provided that they exert a decisive influence on the quality of the final product.
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Zhejiang Honor Biotechnology Co., Ltd.
No. 30, Duchuan South Road, Linhai Industrial Park, Zhejiang Province Chemical API Base