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.
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- Structure:
- Chemical Name:
- 11β-Hydroxy Dienogest
- CAS:
- 86153-39-1
- MF:
- C20H25NO3
- Structure:
- Chemical Name:
- 2H,5H-Pyrano[4,3-b]pyranyl Mupirocin SodiuM IMpurity
- CAS:
- 116182-44-6
- MF:
- C26H43NaO9
- Structure:
- Chemical Name:
- 3-Hydroxy CitalopraM
- CAS:
- 411221-53-9
- MF:
- C20H21FN2O2
- Structure:
- Chemical Name:
- 5-(OxiranylMethoxy)-2,3,4,9-tetrahydrocarbazole
- CAS:
- 58457-32-2
- MF:
- C15H17NO2
- Structure:
- Chemical Name:
- 4'-(Difluoromethoxy)acetanilide
- CAS:
- 22236-11-9
- MF:
- C9H9F2NO2
- Structure:
- Chemical Name:
- EthanediaMide, N1-(5-chloro-2-pyridinyl)-N2-[(1S,2S,4R)-4-[(diMethylaMino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-Methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]aMino]cyclohexyl]-
- CAS:
- 1255529-28-2
- MF:
- C24H30ClN7O4S
- Structure:
- Chemical Name:
- N-carbaMoyl-2-Methyl benzene sulfonaMide
- CAS:
- 39051-77-9
- MF:
- C8H10N2O3S
- Structure:
- Chemical Name:
- Capecitabin iMpurity
- CAS:
- 71609-08-0
- MF:
- C9H12FN3O4
- Structure:
- Chemical Name:
- 4-(4-(4-(4-(((3S,5S)-5-((1H-1,2,4-triazol-1-yl)Methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)Methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2R,3R)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one
- CAS:
- 2243785-97-7
- MF:
- C37H42F2N8O4
- Structure:
- Chemical Name:
- 4-(4-broMo-3-(hydroxyMethyl)phenoxy)benzonitrile
- CAS:
- 906673-45-8
- MF:
- C14H10BrNO2
- Structure:
- Chemical Name:
- ACT 080803
- CAS:
- 1433875-21-8
- MF:
- C16H13Br2N5O2
- Structure:
- Chemical Name:
- L-Alanine, N-[(S)-hydroxyphenoxyphosphinyl]-, 1-Methylethyl ester, (P→3'),(P'→5')-diester with (2'R)-2'-deoxy-2'-fluoro-2'-Methyluridine
- CAS:
- 1337482-17-3
- MF:
- C34H45FN4O13P2
- Structure:
- Chemical Name:
- Pyrido[2,3-d]pyriMidin-7(8H)-one, 2,6-dibroMo-8-cyclopentyl-5-Methyl-
- CAS:
- 1415560-29-0
- MF:
- C13H13Br2N3O
- Structure:
- Chemical Name:
- 1,1'-[1,3-Propanediylbis(oxy)]bis[2,5-dimethylbenzene]
- CAS:
- 415724-02-6
- MF:
- C19H24O2
- Structure:
- Chemical Name:
- (E)-2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethan-1-amine
- CAS:
- 1371535-54-4
- MF:
- C13H17NO
- Structure:
- Chemical Name:
- Donepezil Impurity
- CAS:
- 896134-06-8
- MF:
- C17H15NO4
- Structure:
- Chemical Name:
- 1-(2-chloro-5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
- CAS:
- 928325-68-2
- MF:
- C17H15ClFN3O2S
- Structure:
- Chemical Name:
- N-methyl-N-(4-nitrophenyl)-2-(piperazin-1-yl)acetamide
- CAS:
- 2037385-84-3
- MF:
- C13H19ClN4O3
- Structure:
- Chemical Name:
- N-(3,5-dimethylphenyl)picolinamide
- CAS:
- 439591-67-0
- MF:
- C14H14N2O
- Structure:
- Chemical Name:
- Neratinib Impurity 6
- CAS:
- 1144516-14-2
- MF:
- C26H21ClN6O4
- Structure:
- Chemical Name:
- Bupivacaine Impurity
- CAS:
- 852804-30-9
- MF:
- C22H37N2O
- Structure:
- Chemical Name:
- Pseudomonic Acid D
- CAS:
- 85248-93-7
- MF:
- C26H42O9
- Structure:
- Chemical Name:
- Terazosin Impurity
- CAS:
- 60548-08-5
- MF:
- C19H25N5O4
- Structure:
- Chemical Name:
- 1204612-29-2
- CAS:
- 1204612-29-2
- MF:
- C12H18ClNO2
- Structure:
- Chemical Name:
- (S)-3-(dimethylamino)-1-(thiophen-3-yl)propan-1-ol
- CAS:
- 1384080-56-1
- MF:
- C9H15NOS
- Structure:
- Chemical Name:
- BDJS-SH 4
- CAS:
- 36588-46-2
- MF:
- C12H18N2O2
- Structure:
- Chemical Name:
- 3-Chloro TirofiBan
- CAS:
- 2713130-63-1
- MF:
- C22H35ClN2O5S
- Structure:
- Chemical Name:
- Adefovir Dipivoxil Impurity E
- CAS:
- 116384-54-4
- MF:
- C10H16N5O4P
- Chemical Name:
- Apixaban Impurity 21
- Structure:
- Chemical Name:
- Atorvastatin Impurity 22
- CAS:
- 1821498-27-4
- MF:
- C27H30FNO6
- Structure:
- Chemical Name:
- Azelastine EP Impurity E
- CAS:
- 105279-16-1
- MF:
- C15H9ClO2
- Chemical Name:
- Blonanserin impurity F
- Chemical Name:
- Capecitabine Impurity 9
- Chemical Name:
- Carfilzomib Impurity E
- Chemical Name:
- Cefoxitin EP Impurity B
- Chemical Name:
- Dabigatran Impurity 3
- Structure:
- Chemical Name:
- Dexamethasone EP Impurity K
- CAS:
- 1809224-82-5
- MF:
- C22H26O4
- Structure:
- Chemical Name:
- Esomeprazole Impurity 3
- CAS:
- 1346599-85-6
- MF:
- C26H30N4O4S
- Structure:
- Chemical Name:
- FeBuxostat Impurity 41
- CAS:
- 2428631-67-6
- MF:
- C19H19N3O3S
- Structure:
- Chemical Name:
- Formoterol EP Impurity E
- CAS:
- 1616967-26-0
- MF:
- C20H26N2O4
- Chemical Name:
- Formoterol Impurity 16
- Chemical Name:
- Indacaterol Impurity 11
- Chemical Name:
- Isavuconazole Impurity 14
- Chemical Name:
- Isavuconazole Impurity 19
- Structure:
- Chemical Name:
- Isavuconazole Impurity 24
- CAS:
- 1176988-44-5
- MF:
- C22H17F2N5OS
- Chemical Name:
- Letrozole Impurity 10
- Structure:
- Chemical Name:
- Levofloxacin Impurity 9
- CAS:
- 1797099-76-3
- MF:
- C18H20FN3O4
- Structure:
- Chemical Name:
- N-(5-Formyl-2-hydroxyphenyl)formamide
- CAS:
- 903563-43-9
- MF:
- C8H7NO3
- Chemical Name:
- Nitrendipine Impurity 5
- Chemical Name:
- Posaconazole Impurity 32
- Chemical Name:
- Posaconazole Impurity 61
- Structure:
- Chemical Name:
- Procaterol Impurity 4
- CAS:
- 63235-39-2
- MF:
- C16H20N2O3
- Structure:
- Chemical Name:
- Sitagliptin Impurity 14
- CAS:
- 2072867-07-1
- MF:
- C26H23F9N6O2
- Structure:
- Chemical Name:
- Ticagrelor Impurity N
- CAS:
- 1643378-47-5
- MF:
- C23H29FN6O4S
- Structure:
- Chemical Name:
- carbamic acid, n-[(1r,2r,5s)-5-[(dimethylamino)carbonyl]-2-hydroxycyclohexyl]-, 1,1-dimethylethyl ester
- CAS:
- 929693-30-1
- MF:
- C14H26N2O4
- Chemical Name:
- Valaciclovir iMpurity
- Chemical Name:
- Erlotinib hydrochloride Impurity C
- Chemical Name:
- Linagliptin Impurity B
- Chemical Name:
- Parecoxib Impurity A
- Chemical Name:
- Parecoxib Impurity F
- Structure:
- Chemical Name:
- 2-(4-Benzhydrylpiperazino)ethyl acetoacetate
- CAS:
- 89226-49-3
- MF:
- C23H28N2O3
- Structure:
- Chemical Name:
- Axitinib Impurity a
- CAS:
- 1347304-18-0
- MF:
- C22H18N4O2S
- Structure:
- Chemical Name:
- Cycloocta[b]pyridine, 4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-2-(1-piperazinyl)-
- CAS:
- 132811-84-8
- MF:
- C21H26FN3
- Chemical Name:
- Linagliptin Impurity W
- Structure:
- Chemical Name:
- (R)-4-fluoro-2-((3-methyl-2,4-dioxo-6-(piperidin-3-ylamino)-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile
- MF:
- C18H20FN5O2
- Structure:
- Chemical Name:
- 1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- MF:
- C21H24FN3O4
- Structure:
- Chemical Name:
- ethyl 1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate
- MF:
- C17H18FNO5
- Chemical Name:
- Dapagliflozin Impurity 1
- Chemical Name:
- Ibrutinib Impurity 5
- Structure:
- Chemical Name:
- Imatinib Impurity 4
- CAS:
- 942514-62-7
- MF:
- C30H33N7O
- Structure:
- Chemical Name:
- Macitentan Impurity 2
- CAS:
- 2211054-90-7
- MF:
- C10H8Br2N4O2
- Chemical Name:
- SofosBuvir Impurity 31
- Chemical Name:
- sofosBuvir Impurity 37
- Structure:
- Chemical Name:
- SofosBuvir Impurity 53
- CAS:
- 1015255-46-5
- MF:
- C20H25FN3O9P
- Chemical Name:
- Sofosbuvir Impurity 60
- Chemical Name:
- Tenofovir impurity G
- Structure:
- Chemical Name:
- Ticagrelor Impurity 26
- CAS:
- 2245167-79-5
- MF:
- C21H24F2N6O3S
- Structure:
- Chemical Name:
- Vildagliptin Impurity 19
- CAS:
- 243145-00-8
- MF:
- C10H16N2O2
- Structure:
- Chemical Name:
- Olopatadine Isopropyl ester Hydrochloride
- CAS:
- 1206456-44-1
- MF:
- C24H29NO3
- Chemical Name:
- GLATIRAMER impurity
- Structure:
- Chemical Name:
- Amoxicillin Impurity U
- MF:
- C16H19N3O5S
- Chemical Name:
- Oxacillin Sodium Impurity I(EP)
- Chemical Name:
- Spectinomycin Impurity E
- Structure:
- Chemical Name:
- 3-butyl-3-hydroxy-2-benzofuran-1-one
- CAS:
- 162050-42-2
- MF:
- C12H14O3
- Structure:
- Chemical Name:
- (R)-10-(2,4,5-trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione
- CAS:
- 2088771-61-1
- MF:
- C16H13F6N5O2
- Structure:
- Chemical Name:
- N-((3R,4S)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine
- CAS:
- 1092578-45-4
- MF:
- C20H25N5
- Structure:
- Chemical Name:
- 846023-56-1
- CAS:
- 846023-56-1
- MF:
- C26H31Cl2N5O4
- Structure:
- Chemical Name:
- Prednisone impurity D (EP)
- CAS:
- 10184-69-7
- MF:
- C21H26O4
- Structure:
- Chemical Name:
- Lisinopril EP Impurity G
- CAS:
- 1356839-89-8
- MF:
- C42H60N6O9
- Structure:
- Chemical Name:
- 2-hexanoylbenzoic acid
- CAS:
- 857538-11-5
- MF:
- C13H16O3
- Structure:
- Chemical Name:
- Blonanserin N-Oxide
- CAS:
- 142838-82-2
- MF:
- C23H30FN3O
- Structure:
- Chemical Name:
- Levofloxacin Impurity 11
- CAS:
- 106939-42-8
- MF:
- C9H9F2NO
- Structure:
- Chemical Name:
- Rabeprazole Impurity 2
- CAS:
- 1807988-36-8
- MF:
- C18H19N3O4
- Structure:
- Chemical Name:
- Tenofovir Related Compound 14
- CAS:
- 1244022-52-3
- MF:
- C8H11N5O
- Structure:
- Chemical Name:
- N-(2-methyl-5-nitrophenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide
- MF:
- C18H15N5O3
- Structure:
- Chemical Name:
- N-(5-(benzyl(methyl)amino)-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide
- MF:
- C25H23N5O
- Structure:
- Chemical Name:
- 1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxylic acid
- CAS:
- 956011-26-0
- MF:
- C14H10FN3O2
- Structure:
- Chemical Name:
- Nicorandil Impurity 4 Dinitrate
- CAS:
- 1798026-96-6
- MF:
- C16H17N5O5