Isotretinoin Impurities: Professional Solutions of Reference Standards for...

As a critical drug for moderate-to-severe acne, Isotretinoin’s production and quality control are subject to rigorous regulatory standards. The Chinese Pharmacopoeia (2025 Edition)mandates that...

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CCBs Nitrosamine Impurities——Precise Drug References Empowering Drug...

Nitrosamine impurity control remains a global regulatory priority. For CCBs—the most widely prescribed antihypertensive class—robust identification and quantification of these impurities are cr...

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the first approval of an oro-dispersible film dosage form in China...

Qilu Pharmaceutical’s risperidone oro-dispersible film has been formally approved for market launch by the National Medical Products Administration (NMPA), marking the first approval of an ...

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​​How Does Olopatadine Safeguard Allergy Patients?...

Impurity control is critical for drug efficacy and safety. Olopatadine may generate impurities during synthesis, storage, or metabolism. The Chinese Pharmacopoeia (2025 Edition) mandates limits ...

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​​J&J Submits Oral IL-23 Peptide Drug for FDA Approval: Sustained...

Global pharmaceutical giant Johnson & Johnson (J&J) and Protagonist Therapeutics recently announced the formal submission of a New Drug Application (NDA) to the U.S. Food and Drug Ad...

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Seloxavir Marboxil Tablets Approved: The Quality Control System Behind ...

On July 18, the domestic self-developed anti-influenza oral drug Seloxavir Marboxil Tablets has been officially approved by China‘s National Medical Products Administration (NMPA) for ...

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Mirogabalin ​​ Impurity ——in stock

The mirogabalin molecule contains multiple chiral centers and unsaturated bonds, rendering it susceptible to generating stereoisomers or positional isomer impurities during synthesis and storage, as ...

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Dotinurad Related Impurities​​

As a novel urate-lowering drug, ​​impurity control is a critical step​​ in ensuring its pharmaceutical safety. Dotinurad-related impurities primarily stem from synthesis process byproducts and d...

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​​Mazdutide — World‘s First GCG/GLP-1 Dual-Receptor Agonist for ...

On June 27, Innovent Biologics’ Mazdutide Injection received approval from China‘s National Medical Products Administration (NMPA) for long-term weight control in adults with obesity ...

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Vitamin B6 (Pyridoxine) Impurity

Vitamin B6 is not resistant to high temperatures and is easily destroyed under light and alkaline conditions, with more degradation impurities. Different impurities may also be generated during the...

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​​Consistency Evaluation of Generic Drugs: June 2025 Update...

In June 2025, a total of 27 varieties (39 acceptance numbers) submitted applications for consistency evaluation, 30 varieties of consistency evaluation over-evaluation, 245 deemed to have passed con...

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Loxoprofen Impurity

Notably, brominated intermediates from synthesis may carry potential toxicity, while impurities such as ​​ring-opened degradants​​ and ​​glycerol-esterified byproducts​​ can compromise drug e...

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Groundbreaking COPD Therapy: CTTQ PHARMA‘S TQC3721 Suspens...

CTTQ PHARMA recently announced that its inhaled PDE3/4 dual inhibitor ​​TQC3721 suspension​​ has received approval from China’s Center for Drug Evaluation (CDE) to initiate...

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Enhanced Supervision in Pharmaceutical Regulation​​...

Pharmaceutical companies must urgently implement such as stringenting raw material controls ,Enhancing process validation protocols and advancing trace-level detection capabilities for emerging carc...

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Vitamin K​​ impurity

To address pain points in procurement, SZEB offer a ​​full life-cycle management program​​: We supplies a complete range of Vitamin K impurities, including:Vitamin K1 Impurity Series​...

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Finerenone impurity

SZEB supplies a comprehensive portfolio of Finerenone impurity reference standards, including stereoisomers such as: (S)-Finerenone​​、(R)-Finerenone​​、Finerenone racemate​​，Below i...

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Lipoic Acid Impurity

SZEB supplies a full range of lipoic acid impurities in stock, including the main process impurities in the preparation of lipoic acid, such as: cyclization by-product impurity A , CAS: 12042...

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Vilanterol Impurity——in stock

SZEB ​​ provides a full suite of vilanterol impurities to accelerate generic drug bioequivalence studies and originator process optimization. Our offerings include: ​​N-Nitroso vilanterol ...

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Eltrombopag Impurity

SZEB ​​ specializes in supplying a comprehensive range of eltrombopag impurities, including:EP-specified impurities​​、Eltrombopag olamine​​、Dimer-related impurities​​ These referenc...

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Azithromycin Impurities​​——in stock

Azithromycin A 11,12-cyclic borate 3’-N-Demethyl-3’-N-(phenylsulfonyl) azithromycin 3-Hydroxy azithromycin acid For detailed impurity profiles and inquiries, visit ​​http://www.ex-biotech.c...

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