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:
- Bisoprolol IMpurity
- CAS:
- 2226263-67-6
- MF:
- C18H31NO4
- Chemical Name:
- Decitabine iMpurity 5
- Structure:
- Chemical Name:
- Erlotinib iMpurity 3
- CAS:
- 328528-74-1
- MF:
- C20H22BrN3O4
- Structure:
- Chemical Name:
- LevetiracetaM IMpurity 3
- CAS:
- 1543353-92-9
- MF:
- C8H15NO4
- Chemical Name:
- Sofosbuvir IMpurity
- Structure:
- Chemical Name:
- (3R,4R,5R)-4-(1-Ethylpropoxy)-3-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester
- CAS:
- 204254-94-4
- MF:
- C15H26O7S
- Structure:
- Chemical Name:
- 9,11-Anhydrobudesonide
- CAS:
- 313474-58-7
- MF:
- C25H32O5
- Structure:
- Chemical Name:
- iperazineacetic acid, 4-[(4- chlorophenyl)phenylMethyl]-
- CAS:
- 113740-61-7
- MF:
- C19H21ClN2O2
- Structure:
- Chemical Name:
- EveroliMus-d4
- CAS:
- 1338452-54-2
- MF:
- C53H79D4NO14
- Structure:
- Chemical Name:
- but-3-en-2-one compound with imidazo[1,2-a]pyridine (1:1)
- CAS:
- 106730-70-5
- MF:
- C13H15N3O
- Structure:
- Chemical Name:
- (R)-2-(Boc-aMino)-2-phenylethyl 4-Methylbenzenesulfonate
- CAS:
- 126610-77-3
- MF:
- C20H25NO5S
- Structure:
- Chemical Name:
- (2R,3R,4R,5S)-5-(4-chloro-3-(4-((S)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-2-(2-hydroxyethyl)tetrahydrofuran-2,3,4-triol
- MF:
- C23H27ClO7
- Structure:
- Chemical Name:
- Pyrido[2,3-d]pyriMidin-7(8H)-one, 8-cyclopentyl-5-Methyl-2-[[5-(1-piperazinyl)-2-pyridinyl]aMino]-, hydrochloride (1:)
- CAS:
- 571189-66-7
- MF:
- C22H28ClN7O
- Chemical Name:
- Olaparib iMpurity
- Structure:
- Chemical Name:
- (2S,3R,4R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-5-((S)-1,2-dihydroxyethyl)tetrahydrofuran-3,4-diol
- MF:
- C21H25ClO6
- Structure:
- Chemical Name:
- (R)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl) butanoate .(R)-2-hydroxy-2-phenylacetate
- CAS:
- 1253055-94-5
- MF:
- C19H20F3NO5
- Chemical Name:
- Olaparib iMpurity A
- Structure:
- Chemical Name:
- (1S,2S,3R,5S)-3-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- MF:
- C14H20ClN5O4S
- Structure:
- Chemical Name:
- Methotrexate α-Methyl Ester
- CAS:
- 66147-29-3
- MF:
- C21H24N8O5
- Structure:
- Chemical Name:
- O-Desethyl Azilsartan
- CAS:
- 1442400-68-1
- MF:
- C23H16N4O5
- Structure:
- Chemical Name:
- 17- Phenyl Trinor Prostaglandin F2α Methyl Amide
- CAS:
- 155206-01-2
- MF:
- C24H35NO4
- Chemical Name:
- Posaconazole iMpurity 5
- Structure:
- Chemical Name:
- APST-ZA
- CAS:
- 635705-72-5
- MF:
- C20H22N2O6S
- Structure:
- Chemical Name:
- Topiroxostat Impurity 5
- CAS:
- 1199273-82-9
- MF:
- C14H7N7
- Structure:
- Chemical Name:
- N-Ethoxycarbonyl Ciprofloxacin
- CAS:
- 93594-29-7
- MF:
- C20H22FN3O5
- Structure:
- Chemical Name:
- Norepinephrine Tartrate Impurity G
- CAS:
- 13062-58-3
- MF:
- C22H21NO3
- Structure:
- Chemical Name:
- Vortioxetine Impurity 1
- CAS:
- 1293489-71-0
- MF:
- C17H20N2S
- Structure:
- Chemical Name:
- 4-bromo-2-nitropyridine
- CAS:
- 909712-10-3
- MF:
- C5H3BrN2O2
- Chemical Name:
- Acemetacin Impurity F
- Structure:
- Chemical Name:
- 1,3-Bis(1H-1,2,4-triazol-1-yl)-2-propanone
- CAS:
- 98414-56-3
- MF:
- C7H8N6O
- Structure:
- Chemical Name:
- 2-[[(3aR,4S,6R,6aS)-6-(7-azanyl-5-propylsulfanyl-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,2-dimethyl-4,5,6,6a-tetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl]oxy]ethanol
- CAS:
- 1354945-69-9
- MF:
- C17H26N6O4S
- Chemical Name:
- Vonoprazan Impurity E
- Structure:
- Chemical Name:
- 2-(2-aminobut-3-enyl)propanedioic acid
- CAS:
- 1378466-25-1
- MF:
- C7H11NO4
- Structure:
- Chemical Name:
- Disalicylimide
- CAS:
- 1972-71-0
- MF:
- C14H11NO4
- Structure:
- Chemical Name:
- Atomoxetine impurity D
- CAS:
- 1643684-02-9
- MF:
- C17H21NO
- Structure:
- Chemical Name:
- (E)-2-(6-(methoxycarbonyl)-2-oxoindolin-3-ylidene)-2-phenylacetic acid
- MF:
- C18H13NO5
- Structure:
- Chemical Name:
- 8-Epi-cyanocobalamin
- CAS:
- 41325-63-7
- MF:
- C63H88CoN14O14P
- Structure:
- Chemical Name:
- Lamivudine Impurity 2
- CAS:
- 200396-21-0
- MF:
- C18H27N3O4S
- Structure:
- Chemical Name:
- Lamivudine Impurity 1
- CAS:
- 1235712-40-9
- MF:
- C8H11N3O4S
- Chemical Name:
- Moxifloxacin Related Impurity 3
- Structure:
- Chemical Name:
- Bisoprolol EP Impurity Q
- CAS:
- 1346604-00-9
- MF:
- C16H27NO4
- Structure:
- Chemical Name:
- Levofloxacin N-Oxide
- CAS:
- 117678-37-2
- MF:
- C18H20FN3O5
- Structure:
- Chemical Name:
- Oseltamivir EP Impurity A
- CAS:
- 1391047-93-0
- MF:
- C14H24N2O4
- Structure:
- Chemical Name:
- Quetiapine EP Impurity N
- CAS:
- 1800291-86-4
- MF:
- C29H41N5O3S
- Chemical Name:
- Ceftazidime Impurity
- Structure:
- Chemical Name:
- Chlorhexidine Digluconate Impurity N
- CAS:
- 152504-10-4
- MF:
- C15H25ClN8
- Structure:
- Chemical Name:
- S-Azetidin-3-yl ethanethioate HCl
- CAS:
- 886615-18-5
- MF:
- C5H9NOS
- Chemical Name:
- Olaparib Impurity C
- Chemical Name:
- Olaparib Impurity F
- Chemical Name:
- Dapoxetine Impurity 4
- Chemical Name:
- Glycopyrrolate impurity 3
- Chemical Name:
- Lamotrigine impurity B
- Chemical Name:
- Ramosetron Impurity 3
- Structure:
- Chemical Name:
- Loratadine Impurity 1
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- 1-(Isopropylamino)-3-(4-methylphenoxy)propane-2-ol
- CAS:
- 5790-46-5
- MF:
- C13H21NO2
- Structure:
- Chemical Name:
- Metoprolol IMpurity 6
- MF:
- C15H25NO3
- Chemical Name:
- Pitavastatin Impurity 5
- Chemical Name:
- Prasugrel Impurity C
- Chemical Name:
- Trifluridine Impurity 2
- Chemical Name:
- Cefazolin Impurity 4
- Chemical Name:
- Vonoprazan Impurity 3
- Chemical Name:
- Cinacalcene Impurity I
- Structure:
- Chemical Name:
- Valsartan Impurity 2
- MF:
- C24H29N5O3
- Chemical Name:
- Istradefylline Impurity 2
- Chemical Name:
- Etoricoxib Impurity 3
- Structure:
- Chemical Name:
- Apremilast Impurity 5
- CAS:
- 200710-04-9
- MF:
- C11H13NO4
- Chemical Name:
- Topiroxostat Imp.C
- Structure:
- Chemical Name:
- (3R,4S)-1-(4-chlorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one
- CAS:
- 1700622-08-7
- MF:
- C24H21ClFNO3
- Structure:
- Chemical Name:
- Rabeprazole Impurity 2
- CAS:
- 1163685-31-1
- MF:
- C11H15NO4
- Chemical Name:
- Regorafenib Impurity 8
- Structure:
- Chemical Name:
- Flomoxef Impurity 5
- CAS:
- 134237-56-2
- MF:
- C25H23ClF2N2O6S
- Structure:
- Chemical Name:
- Ranitidine impurity
- CAS:
- 94167-82-5
- MF:
- C10H18N2O
- Chemical Name:
- nicergoline impurity E
- Structure:
- Chemical Name:
- ethyl(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(4-ethoxy-4-oxobutanamido)-2-methylpentanoate
- MF:
- C26H33NO5
- Chemical Name:
- Tacrolimus Impurity C
- Chemical Name:
- Levodopa impurity 5
- Structure:
- Chemical Name:
- (R)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
- CAS:
- 1223404-68-9
- MF:
- C21H22F2N6O2
- Structure:
- Chemical Name:
- Afatinib Impurity 18
- CAS:
- 2316847-95-5
- MF:
- C22H20ClFN4O4
- Structure:
- Chemical Name:
- Ivabradine Impurity 1 Hydrochloride
- CAS:
- 85175-52-6
- MF:
- C16H25ClN2O3
- Chemical Name:
- SofosBuvir Impurity 3
- Structure:
- Chemical Name:
- phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate
- CAS:
- 417722-95-3
- MF:
- C24H18ClN3O5
- Structure:
- Chemical Name:
- Canagliflozin Impurity 10
- CAS:
- 1672658-93-3
- MF:
- C24H25FO6S
- Chemical Name:
- Canagliflozin Impurity F
- Chemical Name:
- Empagliflozin impurity E
- Structure:
- Chemical Name:
- Fasudil Impurity 6
- CAS:
- 2044706-58-1
- MF:
- C11H11NO3S
- Chemical Name:
- Ibrutinib Impurity 11
- Structure:
- Chemical Name:
- Nintedanib impurity I
- CAS:
- 334951-61-0
- MF:
- C30H31N5O4
- Structure:
- Chemical Name:
- (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylic acid compound with 3-benzoyl-2-oxoindoline-6-carboxylic acid
- CAS:
- 1253768-91-0
- MF:
- C16H11NO4
- Structure:
- Chemical Name:
- Everolimus Related Compound 3
- CAS:
- 147438-30-0
- MF:
- C32H49NO9
- Structure:
- Chemical Name:
- (R)-isopropyl 2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate
- CAS:
- 1627824-09-2
- MF:
- C18H17F5NO5P
- Structure:
- Chemical Name:
- Cefuroxime Sodium EP Impurity C
- CAS:
- 69822-88-4
- MF:
- C15H15N3O6S
- Structure:
- Chemical Name:
- Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid
- CAS:
- 76812-49-2
- MF:
- C23H20ClNO8
- Structure:
- Chemical Name:
- Cefuroxime Sodium EP Impurity G
- CAS:
- 97232-98-9
- MF:
- C17H17N3O8S
- Structure:
- Chemical Name:
- 2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone
- CAS:
- 1244949-62-9
- MF:
- C11H14ClN3O
- Structure:
- Chemical Name:
- Cetirizine 3-Chloro Impurity
- CAS:
- 1232460-31-9
- MF:
- C21H25ClN2O3
- Structure:
- Chemical Name:
- Donepezil Impurity 8
- CAS:
- 1808997-65-0
- MF:
- C18H23NO4
- Chemical Name:
- Rivaroxaban Impurity 23
- Structure:
- Chemical Name:
- (Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide
- CAS:
- 1450758-21-0
- MF:
- C5H6N4O2S
- Structure:
- Chemical Name:
- Fosfomycin Trometamol impurity C
- CAS:
- 23001-39-0
- MF:
- C4H12NO6P
- Structure:
- Chemical Name:
- (R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate
- MF:
- C22H23FN2O5