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:
- Rivaroxaban Impurity 36
- CAS:
- 1770812-39-9
- MF:
- C19H17Cl2N3O5S
- Structure:
- Chemical Name:
- (S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate
- CAS:
- 1111177-24-2
- MF:
- C20H23N5O2
- Structure:
- Chemical Name:
- Clopidogrel Impurity C
- CAS:
- 1346605-15-9
- MF:
- C16H18ClNO2S
- Structure:
- Chemical Name:
- Nilotinib genotoxic impurity 2
- CAS:
- 1157857-29-8
- MF:
- C19H15F3N4O3
- Structure:
- Chemical Name:
- NCFJJNFEEPMRAQ-XMMPIXPASA-N
- CAS:
- 1453221-45-8
- MF:
- C35H41F6N3O6
- Chemical Name:
- Gliclazide Impurity E
- Structure:
- Chemical Name:
- Ethyl 1-butanesulfonate
- CAS:
- 2374-68-7
- MF:
- C6H14O3S
- Structure:
- Chemical Name:
- OLANEXIDINE intermediate
- CAS:
- 60852-95-1
- MF:
- C10H20N4
- Structure:
- Chemical Name:
- 1H-Isoindole, octahydro-, trans-
- CAS:
- 10479-63-7
- MF:
- C8H15N
- Structure:
- Chemical Name:
- 1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI)
- CAS:
- 155272-03-0
- MF:
- C18H20N4O4
- Structure:
- Chemical Name:
- Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)-
- CAS:
- 181289-34-9
- MF:
- C9H17NO3
- Structure:
- Chemical Name:
- Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide
- CAS:
- 2614-10-0
- MF:
- C11H14N2O4
- Structure:
- Chemical Name:
- 4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate
- CAS:
- 65141-48-2
- MF:
- C8H10N4O7
- Structure:
- Chemical Name:
- 4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE
- CAS:
- 112809-52-6
- MF:
- C17H11N5
- Structure:
- Chemical Name:
- Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)-
- CAS:
- 93239-37-3
- MF:
- C24H30O5
- Chemical Name:
- Tadalafil EP impurity E
- Structure:
- Chemical Name:
- TF-A
- CAS:
- 134965-85-8
- MF:
- C12H7ClN6
- Structure:
- Chemical Name:
- myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside
- CAS:
- 142449-93-2
- MF:
- C26H28O17
- Structure:
- Chemical Name:
- 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione
- CAS:
- 69321-95-5
- MF:
- C9H12N2O7
- Structure:
- Chemical Name:
- 2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE
- CAS:
- 91219-90-8
- MF:
- C11H15NO3
- Structure:
- Chemical Name:
- (S)-1-(2-Aminoacetyl)-pyrrolidine-2-carbonitrile
- CAS:
- 914070-99-8
- MF:
- C7H11N3O
- Structure:
- Chemical Name:
- 1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)urea
- CAS:
- 1388858-78-3
- MF:
- C19H23FN2O2
- Structure:
- Chemical Name:
- 1,4,7,10-Tetraazabicyclo[8.2.2]tetradecan-11-one
- CAS:
- 220182-11-6
- MF:
- C10H20N4O
- Structure:
- Chemical Name:
- Ropivacaine EP Impurity D
- CAS:
- 98626-59-6
- MF:
- C16H24N2O
- Structure:
- Chemical Name:
- Bendamustine Impurity 16
- CAS:
- 914626-65-6
- MF:
- C19H18N6O4
- Structure:
- Chemical Name:
- (S)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine hydrochloride
- CAS:
- 959392-22-4
- MF:
- C18H19NOS
- Structure:
- Chemical Name:
- phenyl (R)-methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)carbamate
- CAS:
- 603996-87-8
- MF:
- C8H11NO2S
- Chemical Name:
- Aprepitant Impurity 23
- Chemical Name:
- Canagliflozin impurity H
- Structure:
- Chemical Name:
- Cefazolin Impurity 9
- CAS:
- 1322626-65-2
- MF:
- C14H15N9O3S3
- Structure:
- Chemical Name:
- Dapagliflozin Impurity 20
- CAS:
- 2040305-09-5
- MF:
- C29H33ClO10
- Structure:
- Chemical Name:
- Edaravone Impurity 10
- CAS:
- 710307-89-4
- MF:
- C10H12N2O2
- Chemical Name:
- Empagliflozin Impurity 23
- Structure:
- Chemical Name:
- Entecavir Impurity 3
- CAS:
- 1391053-94-3
- MF:
- C12H15N5O4
- Chemical Name:
- IBrutinib Impurity C
- Chemical Name:
- Imatinib impurity 12
- Chemical Name:
- Isavuconazole Impurity 20
- Chemical Name:
- Isavuconazole Impurity 26
- Chemical Name:
- Istradefylline impurity D
- Structure:
- Chemical Name:
- Leuprorelin EP Impurity F
- CAS:
- 1872435-00-1
- MF:
- C59H84N16O12
- Chemical Name:
- Linagliptin Impurity 40
- Structure:
- Chemical Name:
- Minocycline N-Hydroxymethyl Impurity
- CAS:
- 1075240-33-3
- MF:
- C24H29N3O8
- Structure:
- Chemical Name:
- Mivacurium Chloride Impurity 3
- CAS:
- 740777-60-0
- MF:
- C33H46NO9+
- Structure:
- Chemical Name:
- Mupirocin EP Impurity E
- CAS:
- 71087-96-2
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- N-Acetyl-Phe-Octreotide
- CAS:
- 83795-61-3
- MF:
- C51H68N10O11S2
- Chemical Name:
- Nifuratel Impurity 7
- Structure:
- Chemical Name:
- Norepinephrine EP Impurity D
- CAS:
- 1932110-67-2
- MF:
- C9H13NO3
- Chemical Name:
- Olaparib Impurity 4
- Chemical Name:
- Paclitaxel EP Impurity M
- Structure:
- Chemical Name:
- Parecoxib Sodium Impurity H
- CAS:
- 501093-49-8
- MF:
- C16H14N2O4S
- Chemical Name:
- Posaconazole Impurity 10
- Structure:
- Chemical Name:
- Posaconazole Impurity 63
- CAS:
- 208187-15-9
- MF:
- C20H26F2O4
- Structure:
- Chemical Name:
- (S)-4,5,6,7-Tetrahydro-N2,N6-propionyl-2,6-benzothiazolediaMine
- CAS:
- 1373869-91-0
- MF:
- C11H17N3O2
- Chemical Name:
- SofosBuvir impurity 62
- Structure:
- Chemical Name:
- Tamoxifen EP Impurity E
- MF:
- C26H29NO
- Chemical Name:
- Tenofovir impurity P
- Structure:
- Chemical Name:
- Tirofiban Impurity 3
- CAS:
- 1346918-32-8
- MF:
- C13H19NO5S
- Chemical Name:
- Trelagliptin Impurity 19
- Structure:
- Chemical Name:
- N-((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine oxide
- CAS:
- 2028267-73-2
- MF:
- C16H20N6O2
- Structure:
- Chemical Name:
- D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-methoxyphenyl)methyl]phenyl]-, (1S)-
- CAS:
- 333359-90-3
- MF:
- C20H23ClO6
- Chemical Name:
- Flucloxacillin Sodium Impurity E
- Chemical Name:
- Amifostine Impurity 1
- Chemical Name:
- Clindamycin Phosphate EP Impurity H
- Structure:
- Chemical Name:
- 2-Thia-5-azabicyclo[2.2.1]heptane-5-carboxylic acid, 3-oxo-, (4-nitrophenyl)methyl ester, (1S,4S)-
- CAS:
- 151072-00-3
- MF:
- C13H12N2O5S
- Structure:
- Chemical Name:
- Brexpiprazole Impurity
- CAS:
- 2116542-21-1
- MF:
- C38H40N4O4S
- Structure:
- Chemical Name:
- 4-(1-(2,3-dimethylphenyl)propyl)-1H-imidazole
- CAS:
- 86347-62-8
- MF:
- C14H18N2
- Structure:
- Chemical Name:
- Atomoxetine EP Impurity A
- CAS:
- 873310-33-9
- MF:
- C16H20ClNO
- Structure:
- Chemical Name:
- Famciclovir Impurity 12
- CAS:
- 122497-20-5
- MF:
- C12H15N5O4
- Structure:
- Chemical Name:
- Levofloxacin Impurity 22
- CAS:
- 177472-29-6
- MF:
- C20H25F2N3O4
- Structure:
- Chemical Name:
- Methylprednisolone EP Impurity E
- CAS:
- 229019-44-7
- MF:
- C21H28O4
- Structure:
- Chemical Name:
- Pantoprazole Impurity 1
- CAS:
- 812664-93-0
- MF:
- C16H14ClF2N3O4S
- Structure:
- Chemical Name:
- Ticagrelor Related Compound 38D-Tartrate
- CAS:
- 2165881-71-8
- MF:
- C10H19NO4
- Structure:
- Chemical Name:
- 1-(1-BENZOTHIOPHEN-7-YL)PIPERAZINE
- CAS:
- 105685-06-1
- MF:
- C12H14N2S
- Structure:
- Chemical Name:
- 4-methyl-N-(2-methyl-5-nitrophenyl)-6-(pyridin-3-yl)pyrimidin-2-amine
- MF:
- C17H15N5O2
- Structure:
- Chemical Name:
- Afatinib Impurity 21
- CAS:
- 2044709-72-8
- MF:
- C18H16F2N4O2
- Structure:
- Chemical Name:
- trans-Carboprost
- CAS:
- 76498-29-8
- MF:
- C21H36O5
- Structure:
- Chemical Name:
- N-[[2-(1H-Tetrazol-5-Yl)[1,1-Biphenyl]-4-Yl]Methyl]Amine(WXC00176)
- CAS:
- 147225-68-1
- MF:
- C14H13N5
- Chemical Name:
- Atracurium Impurity 26
- Chemical Name:
- Aztreonam Impurity 2
- Structure:
- Chemical Name:
- Benazepril Impurity E
- MF:
- C24H28N2O5
- Chemical Name:
- Canagliflozin Impurity 44
- Chemical Name:
- Clotrimazole Impurity 3
- Structure:
- Chemical Name:
- Dithio-Desethyl Carbodenafil
- CAS:
- 1610830-81-3
- MF:
- C22H28N6OS2
- Chemical Name:
- Erlotinib Impurity 57
- Chemical Name:
- Esomeprazole Impurity 41
- Chemical Name:
- Oseltamivir Impurity 29
- Chemical Name:
- Pramipexole Impurity 36
- Structure:
- Chemical Name:
- Riboflavin Impurity 1
- CAS:
- 64480-68-8
- MF:
- C16H20N2O7
- Chemical Name:
- Rocuronium Bromide Impurity 10
- Structure:
- Chemical Name:
- Rocuronium Bromide Impurity 23
- MF:
- C23H39NO3
- Chemical Name:
- Adefovir Impurity 10
- Chemical Name:
- Apremilast Impurity SY
- Chemical Name:
- Atracurium Impurity L
- Chemical Name:
- Cefoxitin EP Impurity G
- Chemical Name:
- Dextrorotation lansoprazole Impurity L
- Chemical Name:
- lansoprazole Impurity 25
- Chemical Name:
- Mirabegron Enantiomer Impurity
- Chemical Name:
- Ropivacaine Impurity 44
- Chemical Name:
- Ropivacaine Impurity 7
- Chemical Name:
- Sugammadex sodium Org199010-1 Impurity