Organisations and their Roles
Product quality tests assess physical, chemical and microbial attributes. Product performance tests assess drug release from the dosage form concerned or, in the case of aerosols, particle size distribution.
Like Ph.Eur., USP also produces a bi-monthly publication entitled “Pharmacopeial Forum”, which contains discussion documents relating to new and/or amended chapters and monographs.
NEW USP 38 CHAPTERS <1> to <5>
Product Tests for Quality
Product Tests for Performance
Route of Administration
Site of Release
Typical Dose Forms
Injections, particles, liposomes, implants, stents
<1001> Under development
Injections & Implanted Drug Products (Parentals) Chapter <1>
Body tissues and fluids
<1>
<701> <711>
Tablets and Capsules, Liquids
Oral Drug Products Chapter <2>
<2>
Oral
Semisolids, Transdermal Patches
<724> <1724>
Topical and Transdermal Drug Products Chapter <3>
Skin
<3>
Ear, eye, nose, throat, urether, vagina, rectum
Mucosal Drug Products Chapter <4>
Various see <4>
<4>
<1004>
<601>, <602> <603>, <604>, <1601>, <1602>
Aerosols, sprays, powders
Inhalation and Nasal Drug Products Chapter <5>
<5>
Lung, nasal cavity
11
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