Standard
In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.
According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.
In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.
International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.
Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.
- Structure:
- Chemical Name:4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylicacid, 5,6-dihydro-8-hydroxy-5-methyl-6-oxo-, ethyl ester
- CAS:131666-45-0
- MF:C15H15N3O4
- Structure:
- Chemical Name:α,α-Bis[2-(dimethylamino)ethyl]-
- CAS:1246816-57-8
- MF:C16H24ClN3
- Structure:
- Chemical Name:(3R,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester
- CAS:125971-93-9
- MF:C11H19NO4
- Structure:
- Chemical Name:2-Desethoxy-2-hydroxy-2H-2-ethyl Candesartan Cilexetil
- CAS:1185256-03-4
- MF:C33H34N6O6
- Structure:
- Chemical Name:D-(-)-3-Acetylthio-2-methylpropionic acid
- CAS:76497-39-7
- MF:C6H10O3S
- Structure:
- Chemical Name:5,4'-DIHYDROXY-7-METHOXYISOFLAVONE-4'-O-GLUCOSIDE
- CAS:89595-66-4
- MF:C22H22O10
- Structure:
- Chemical Name:OLANEXIDINE
- CAS:146510-36-3
- MF:C17H27Cl2N5
- Structure:
- Chemical Name:1-(2-ETHOXY-ETHYL)-1,3-DIHYDRO-BENZOIMIDAZOL-2-ONE
- CAS:101953-61-1
- MF:C11H14N2O2
- Structure:
- Chemical Name:3-Cyano-4-(2-methylpropoxy)benzenecarbothioamide
- CAS:163597-57-7
- MF:C12H14N2OS
- Structure:
- Chemical Name:1-BOC-4-(2-AMINO-4-PYRIDINYL)-PIPERAZINE
- CAS:571189-23-6
- MF:C14H22N4O2
- Structure:
- Chemical Name:1,3,5,7-Tetranitroadamantane
- CAS:75476-36-7
- MF:C10H12N4O8
- Structure:
- Chemical Name:Fexofenadinone
- CAS:76811-98-8
- MF:C32H37NO4
- Structure:
- Chemical Name:6-(3-CHLOROPHENYL)-1,3,5-TRIAZINE-2,4-DIAMINE
- CAS:4514-54-9
- MF:C9H8ClN5
- Structure:
- Chemical Name:α-Methyl-3,4-dihydroxy-L-phenylalanine methyl ester
- CAS:18181-08-3
- MF:C11H15NO4
- Structure:
- Chemical Name:(6R,7R)-3-Chloromethyl-7-methoxy-8-oxo-7-(p-toluoylamino)-5-oxa-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid diphenylmethyl ester
- CAS:68314-38-5
- MF:C30H27ClN2O6
- Structure:
- Chemical Name:Methyl a-formylphenylacetate
- CAS:5894-79-1
- MF:C10H10O3
- Structure:
- Chemical Name:1-Butanesulfonic acid methyl ester
- CAS:2374-69-8
- MF:C5H12O3S
- Chemical Name:Free and total Chlorine, ion specific meter
- CAS:
- MF:
- Structure:
- Chemical Name:N-Desethyl-N-propyl Oxybutynin
- CAS:1215677-72-7
- MF:C23H33NO3
- Structure:
- Chemical Name:3-Oxo Atorvastatin
- CAS:887196-30-7
- MF:C33H33FN2O5
- Structure:
- Chemical Name:Octyl Orlistat
- CAS:1243011-56-4
- MF:C31H57NO5
- Structure:
- Chemical Name:1,2,3,4-Tetrahydro-4,8-dihydroxy-2-methyl-isoquinoline
- CAS:23824-25-1
- MF:C10H13NO2
- Structure:
- Chemical Name:(E)-Cefetamet Pivoxil
- CAS:1705612-82-3
- MF:C20H25N5O7S2
- Structure:
- Chemical Name:{3-[2-(DiMethylaMino)ethyl]-5-[(pyrrolidine-1-yl)sulfonylMethyl]-1H-indol-1-yl}Methanol
- CAS:1018676-02-2
- MF:C18H27N3O3S
- Structure:
- Chemical Name:{3-[2-(DiMethylaMino)ethyl]-5-[(pyrrolidine-1-yl)sulfonylMethyl]-1H-indol-1-yl}Methanol
- CAS:1018676-02-2
- MF:C18H27N3O3S
- Structure:
- Chemical Name:8-Dechloro-9-chloro Desloratadine
- CAS:117811-13-9
- MF:C19H19ClN2
- Structure:
- Chemical Name:Acyclovir L-Isoleucinate
- CAS:142963-63-1
- MF:C14H22N6O4
- Structure:
- Chemical Name:Aripiprazole N4-Oxide
- CAS:573691-11-9
- MF:C23H27Cl2N3O3
- Structure:
- Chemical Name:Carvedilol Bisalkylpyrocatechol IMpurity
- CAS:1346602-98-9
- MF:C40H42N4O6
- Structure:
- Chemical Name:Decarboxyl Ofloxacin
- CAS:123155-82-8
- MF:C17H20FN3O2
- Structure:
- Chemical Name:o-AdaMantylanisole
- CAS:43109-77-9
- MF:C17H22O
- Structure:
- Chemical Name:Hydroxyzine Acetic Acid Dihydrochloride
- CAS:83881-56-5
- MF:C23H29ClN2O4
- Structure:
- Chemical Name:(S)-Duloxetine SuccinaMide
- CAS:199191-66-7
- MF:C22H23NO4S
- Structure:
- Chemical Name:4-Acetyl Rhein
- CAS:875535-36-7
- MF:C17H10O7
- Structure:
- Chemical Name:1-(2,6-dichlorophenyl)piperazine
- CAS:63386-61-8
- MF:C10H12Cl2N2
- Structure:
- Chemical Name:1-(2,6-dichlorophenyl)piperazine
- CAS:63386-61-8
- MF:C10H12Cl2N2
- Structure:
- Chemical Name:Ropivacaine N-Oxide
- CAS:1391053-59-0
- MF:C17H26N2O2
- Structure:
- Chemical Name:Methyl 2-CarbaMoylbenzoate
- CAS:90564-02-6
- MF:C9H9NO3
- Structure:
- Chemical Name:3-vinylphenyl ethyl(Methyl)-carbaMate
- CAS:1346602-84-3
- MF:C12H15NO2
- Structure:
- Chemical Name:AMisulpride IMpurity D
- CAS:71676-00-1
- MF:C16H25N3O4S
- Structure:
- Chemical Name:1,2-Benzenedicarboxylic acid, 3-aMino-, 1,2-diethyl ester
- CAS:62351-80-8
- MF:C12H15NO4
- Chemical Name:AFuroseMide IMp. A (EP)
- CAS:
- MF:
- Structure:
- Chemical Name:(1R)-3,4-Dihydro-1-phenyl-2(1H)-isoquinolinecarboxylic acid ethyl ester
- CAS:180468-41-1
- MF:C18H19NO2
- Structure:
- Chemical Name:2-[4-[(RS)-(4-Chlorophenyl)phenylMethyl]-piperazin-1-yl]ethanolDihydrochloride
- CAS:
- MF:C19H25Cl3N2O
- Structure:
- Chemical Name:CAPECITABINE related substance USP
- CAS:1262133-68-5
- MF:C20H30FN3O9
- Structure:
- Chemical Name:4-AMino-N-[(1-ethyl-2-pyrrolidinyl)Methyl]-5-(ethylsulfonyl)- 2-MethoxybenzaMide N-Oxide
- CAS:71676-01-2
- MF:C17H27N3O5S
- Structure:
- Chemical Name:3-[(4-AMino-2-Methyl-5-pyriMidinyl)Methyl]-4-Methyl-5-[2-(sulfooxy)ethyl]thiazoliuM Inner Salt
- CAS:2380-61-2
- MF:C12H16N4O4S2
- Structure:
- Chemical Name:1,4-Bis-[4-[4-Methyl-3-[[4-(pyridin-3-yl)pyriMidin-2-yl]aMino]phenyl]carbaMoyl]benzylpiperazine
- CAS:1365802-18-1
- MF:C52H48N12O2
- Structure:
- Chemical Name:[6R-[6α,7β(R*)]]-7-[(AMinophenylacetyl)aMino]-3-Methyl-8-oxo-5-thia-1-azabicyclo[4.2.0
- CAS:79750-46-2
- MF:C16H17N3O4S
- Structure:
- Chemical Name:SalMeterol EP IMpurity D
- CAS:1391052-04-2
- MF:C34H47NO7
- Structure:
- Chemical Name:3-Pyridinecarboxylic Acid 2-AMinoethyl Ester Dihydrochloride
- CAS:87330-70-9
- MF:C8H11ClN2O2
- Structure:
- Chemical Name:1β-Hydroxy-6α-Methyl-1,4-androstadiene-3,17-dione
- CAS:61919-52-6
- MF:C20H26O3
- Structure:
- Chemical Name:5-Fluoro ent-LaMivudine Acid D-Menthol Ester
- CAS:764659-79-2
- MF:C18H26FN3O4S
- Structure:
- Chemical Name:Tricyclo[3.3.1.13,7]decan-1-aMine, 3,5,7-triMethyl-, hydrochloride
- CAS:15210-60-3
- MF:C13H24ClN
- Structure:
- Chemical Name:4'-Hydroxy TorseMide
- CAS:99300-67-1
- MF:C16H20N4O4S
- Structure:
- Chemical Name:7,10-Dimethoxy-10-DAB III
- CAS:183133-94-0
- MF:C31H40O10
- Chemical Name:IMp. F (EP): 3-(4-Hydroxyphenyl)pyrazin-2-ol
- CAS:
- MF:
- Structure:
- Chemical Name:PeMetrexed EP IMpurity D
- CAS:144051-68-3
- MF:C25H28N6O9
- Structure:
- Chemical Name:SuMatriptan EP IMpurity F
- CAS:2074615-63-5
- MF:C13H17N3O2S
- Structure:
- Chemical Name:2-[[(5-hydroxy-1H-benziMidazol-2-yl)sulfinyl]Methyl]-3,5-diMethyl-1-4(1H)-pyridone
- CAS:
- MF:C15H15N3O3S
- Chemical Name:Perindopril Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:4-Acetoxyisophthalic Acid
- CAS:5985-26-2
- MF:C10H8O6
- Structure:
- Chemical Name:Ganciclovir Dipropionate
- CAS:86357-20-2
- MF:C15H21N5O6
- Structure:
- Chemical Name:IMp. A (EP): (RS)-2-Chloro-N-(2-Methylphenyl)-PropanaMide
- CAS:39084-88-3
- MF:C10H11Cl2NO
- Structure:
- Chemical Name:3-((butyryloxy)Methyl) 5-Methyl 4-(2',3'-dichlorophenyl)-2,6-diMethylpyridine-3,5-dicarboxylate
- CAS:188649-48-1
- MF:C21H21Cl2NO6
- Structure:
- Chemical Name:Bis Valacyclovir (~90%)
- CAS:1356019-51-6
- MF:C27H40N12O8
- Structure:
- Chemical Name:Flupirtine DiMer
- CAS:1417916-52-9
- MF:C30H32F2N8O4
- Structure:
- Chemical Name:(S)-2-((R)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-4-benzylMorpholin-3-one
- CAS:327623-36-9
- MF:C21H19F6NO3
- Structure:
- Chemical Name:3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide
- CAS:2304623-36-5
- MF:C16H14N2O3S
- Structure:
- Chemical Name:(S)-2-(3,4-Difluorophenyl)oxirane
- CAS:1006376-63-1
- MF:C8H6F2O
- Structure:
- Chemical Name:EsoMeprazole iMpurity
- CAS:1424857-86-2
- MF:C11H15NO3
- Structure:
- Chemical Name:AMoxicillin iMpurity L
- CAS:
- MF:C16H19N3O5S
- Structure:
- Chemical Name:AMoxicillin iMpurity L
- CAS:
- MF:C16H19N3O5S
- Chemical Name:Azilsartan iMpurity G
- CAS:
- MF:
- Structure:
- Chemical Name:(R)-N-(1-(naphthalen-1-yl)ethyl)-3-(M-tolyl)propan-1-aMine
- CAS:253337-60-9
- MF:C22H25N
- Structure:
- Chemical Name:3-((3R,4R)-4-Methyl-3-(Methyl(7H-pyrrolo[2,3-d]pyriMidin-4-yl)aMino)piperidin-1-yl)-3-oxopropanaMide
- CAS:1675248-19-7
- MF:C16H22N6O2
- Structure:
- Chemical Name:Blonanserin iMpurity
- CAS:132810-83-4
- MF:C23H30FN3
- Structure:
- Chemical Name:Deferasirox iMpurity
- CAS:1688656-83-8
- MF:C42H28N6O8S
- Structure:
- Chemical Name:Lercanidipine iMpurity
- CAS:320750-19-4
- MF:C37H43N3O6
- Structure:
- Chemical Name:AMpicillin EP IMpurity J
- CAS:6489-58-3
- MF:C13H20N2O4S
- Structure:
- Chemical Name:Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-BenzenediacetaMide)
- CAS:120512-04-1
- MF:C17H23N5O2
- Structure:
- Chemical Name:Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-BenzenediacetaMide)
- CAS:120512-04-1
- MF:C17H23N5O2
- Structure:
- Chemical Name:CefathiaMidine Lactone
- CAS:905712-22-3
- MF:C17H24N4O4S2
- Structure:
- Chemical Name:Cinacalcet IMpurity 9
- CAS:802918-36-1
- MF:C22H24F3N
- Structure:
- Chemical Name:Doxorubicin IMpurity B
- CAS:106401-68-7
- MF:C29H34BrNO11
- Chemical Name:EzetiMibe IMpurity B
- CAS:
- MF:
- Structure:
- Chemical Name:Fluconazole IMpurity [1, 3-Bis(1H-1, 2, 4-Triazole-1-yl)propan-2-one]
- CAS:1449785-88-9
- MF:C10H7F2N3O
- Structure:
- Chemical Name:HydroxyMethylidene thione
- CAS:1320360-86-8
- MF:C15H18N4OS
- Chemical Name:Lansoprazole IMpurity I
- CAS:
- MF:
- Structure:
- Chemical Name:Lapatinib IMpurity 10
- CAS:1152131-73-1
- MF:C26H17ClFN3O4
- Chemical Name:Metronidazole IMpurity D
- CAS:
- MF:
- Chemical Name:PraMipexole IMpurity V (PraMipexole IMpurity Z)
- CAS:
- MF:
- Structure:
- Chemical Name:Prasugrel Acetyl IMpurity
- CAS:1443034-67-0
- MF:C18H18FNO3S
- Chemical Name:Propofol IMpurity G
- CAS:
- MF:
- Structure:
- Chemical Name:SalMeterol IMpurity A
- CAS:
- MF:C25H37NO4
- Structure:
- Chemical Name:Sitagliptin Defuoro IMpurity 3
- CAS:851307-12-5
- MF:C15H19F2NO4
- Structure:
- Chemical Name:Sitagliptin N-Boc IMpurity
- CAS:486460-23-5
- MF:C21H23F6N5O3
- Chemical Name:SulbactaM IMpurity D
- CAS:
- MF:
- Chemical Name:Valsartan N2-Trityl IMpurity
- CAS:
- MF:
- Structure:
- Chemical Name:Vardenafil IMpurity 3
- CAS:1255919-01-7
- MF:C26H30N6O4S