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:
- 2-[1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyriMidine-4,5,6-triaMine
- CAS:
- 428854-24-4
- MF:
- C17H15FN8
- Structure:
- Chemical Name:
- AR-C 124910XX
- CAS:
- 220347-05-7
- MF:
- C21H24F2N6O3S
- Structure:
- Chemical Name:
- Doxazosin iMpurity
- CAS:
- 1219803-95-8
- MF:
- C23H26ClN5O5
- Chemical Name:
- Montelukast iMpurity
- Structure:
- Chemical Name:
- Vildagliptin iMpurity A-F
- CAS:
- 1846606-32-3
- MF:
- C7H10N2O3
- Structure:
- Chemical Name:
- NM-2201
- CAS:
- 837112-21-7
- MF:
- C24H22FNO2
- Structure:
- Chemical Name:
- 5a-17-(3-Pyridyl)-16-androstene-3-one
- MF:
- C24H31NO
- Chemical Name:
- AMpicillin EP IMpurity E
- Chemical Name:
- Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi
- Chemical Name:
- AtracuriuM IMpurity H (Mixture of cis, trans(H1), cis, cis(H2) tans, trans IsoMer)
- CAS:
- 1248429-33-5
- Chemical Name:
- Ceftriaxone IMpurit B
- Chemical Name:
- Flucloxacillin IMpurity F
- Structure:
- Chemical Name:
- IMidafenacin IMpurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-IMidazoliuM Phosphate)
- CAS:
- 562091-56-9
- MF:
- C20H22N3O4P
- Structure:
- Chemical Name:
- Lercanidipine IMpurity B
- CAS:
- 1119226-97-9
- MF:
- C35 H37 N3 O6
- Structure:
- Chemical Name:
- Milrinone IMpurity 2
- CAS:
- 400063-10-7
- MF:
- C12H7N3O2
- Structure:
- Chemical Name:
- Moxifloxacin Decarboxy Analog
- CAS:
- 1322062-57-6
- MF:
- C20H24FN3O2
- Structure:
- Chemical Name:
- Naratriptan IMpurity E
- CAS:
- 1346746-73-3
- MF:
- C20H32N4O4S2
- Structure:
- Chemical Name:
- PraMipexole DiMer IMpurity II
- CAS:
- 2206826-82-4
- MF:
- C20H32N6S2
- Structure:
- Chemical Name:
- rac Des(isopropylaMino) Acebutolol Diol
- CAS:
- 96480-91-0
- MF:
- C15H21NO5
- Structure:
- Chemical Name:
- (17α)-17-Hydroxy-3-oxo-19-norpregna-5(10),9(11)-diene-21-nitrile
- CAS:
- 106111-42-6
- MF:
- C20H25NO2
- Structure:
- Chemical Name:
- (3S)-N-[[(1S)-1,2,3,4-Tetrahydro-1-naphthalenyl]Methyl]-1-azabicyclo[2.2.2]octan-3-aMine
- CAS:
- 177793-80-5
- MF:
- C18H26N2
- Structure:
- Chemical Name:
- 4-(4-Fluorophenyl)-1-Methyl-
- CAS:
- 1012886-75-7
- MF:
- C12H15ClFN
- Structure:
- Chemical Name:
- 5'(S)-Hydroxy SiMvastatin DISCONTINUED
- CAS:
- 149949-05-3
- MF:
- C25H38O6
- Structure:
- Chemical Name:
- 5'-Epi-LaMivudine
- CAS:
- 136846-20-3
- MF:
- C8H11N3O3S
- Structure:
- Chemical Name:
- N-ForMyl-D-ribofuranosyl-3-guanylurea (α/β-Mixture)
- CAS:
- 686299-20-7
- MF:
- C8H14N4O6
- Structure:
- Chemical Name:
- ethyl 2-(3-hydroxyphenyl)-4-methylthiazole-5-Carboxylate
- CAS:
- 209538-87-4
- MF:
- C13H13NO3S
- Structure:
- Chemical Name:
- Pyridine, 3-Methoxy-2-Methyl-4-nitro-, 1-oxide
- CAS:
- 15931-25-6
- MF:
- C7H8N2O4
- Structure:
- Chemical Name:
- 1H,3H,5H-pyrrolo[1,2-a]thiazolo[3,4-d]pyrazine5,8,10(5aH,10aH)-trione,dihydro-
- CAS:
- 161771-76-2
- MF:
- C9H10N2O3S
- Structure:
- Chemical Name:
- (Z)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl)but-2-enoate
- CAS:
- 881995-70-6
- MF:
- C11H10F3NO2
- Structure:
- Chemical Name:
- 6-(benzyloxy)-8-(2-broMoacetyl)-2H-benzo[b][1,4]oxazin-3(4H)-one
- CAS:
- 926319-53-1
- MF:
- C17H14BrNO4
- Structure:
- Chemical Name:
- (2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2phenylethoxy) carbonyl]propyl]aMino]propanoyl]pyrrolidine-2-carboxylic acid
- MF:
- C26H31N2O5
- Structure:
- Chemical Name:
- 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid (Diketopiperazine)
- MF:
- C29H42N8O18S4
- Chemical Name:
- Methoxyvinpocetine
- Structure:
- Chemical Name:
- Butanoic acid, 4-chloro-3-hydroxy-, (3S)-
- CAS:
- 106941-19-9
- MF:
- C4H7ClO3
- Structure:
- Chemical Name:
- 2- hydroxyl olopatadine hydrochloride iMpurity
- CAS:
- 1331822-32-2
- MF:
- C21H23NO4
- Chemical Name:
- Anastrozole iMpurity D
- Chemical Name:
- EMtricitabine iMpurity D
- Chemical Name:
- IMp. D (EP) as SodiuM Salt
- Chemical Name:
- RocuroniuMbroMide iMpurity G
- Structure:
- Chemical Name:
- 5,11-bisthio-(R,R)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,8-diketone
- CAS:
- 72744-67-3
- MF:
- C8H10N2O2S2
- Structure:
- Chemical Name:
- Rosuvastatin Substituted Hydroxy Pentenoic Acid
- CAS:
- 910867-11-7
- MF:
- C20H24FN3O5S
- Structure:
- Chemical Name:
- EthanediaMide iMpurity k
- CAS:
- 2803419-58-9
- MF:
- C2H4N2O2
- Structure:
- Chemical Name:
- (1S,2S,3R,5S)-3-(7-hydroxy-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:
- 1445580-43-7
- MF:
- C14H21N5O5S
- Structure:
- Chemical Name:
- D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-(hydroxyMethyl)-1-(1H-1,2,4-triazol-1-yl)-
- CAS:
- 160709-02-4
- MF:
- C14H15F2N3O2
- Structure:
- Chemical Name:
- Bivalirudin iMpurity
- CAS:
- 72378-50-8
- MF:
- C6H8N2O4
- Structure:
- Chemical Name:
- 2-(4-tert-Butyl-3-hydroxy-2,6-dimethylphenyl)acetic acid
- CAS:
- 55699-12-2
- MF:
- C14H20O3
- Structure:
- Chemical Name:
- (S)-Fesoterodine FuMarate
- CAS:
- 1431511-18-0
- MF:
- C30H41NO7
- Structure:
- Chemical Name:
- (3S)-10-(4-Ethyl-1-piperazinyl)-9-fluoro-2,3-dihydro-3-Methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (Levofloxacin IMpurity)
- CAS:
- 106939-30-4
- MF:
- C19H22FN3O4
- Structure:
- Chemical Name:
- (6S,12bR)-6-(1,3-Benzodioxol-5-yl)-2,3,7,12b-tetrahydro-2-Methyl-pyrazino[1',2':1,5]pyrrolo[3,4-b]quinoline-1,4,12(6H)-trione
- CAS:
- 531500-48-8
- MF:
- C22H17N3O5
- Structure:
- Chemical Name:
- 1-(3,5-Dihydroxyphenyl)-2-[(1,1-diMethylethyl)(phenylMethyl)aMino]ethanone HydrobroMide
- CAS:
- 94109-61-2
- MF:
- C19H23NO3
- Structure:
- Chemical Name:
- 2-Methyl-5-(3-(4-(Methylsulfonyl)phenyl)furan-2-yl)pyridine
- CAS:
- 307531-96-0
- MF:
- C17H15NO3S
- Structure:
- Chemical Name:
- 3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzenesulfonic Acid
- CAS:
- 437717-43-6
- MF:
- C17H20N4O5S
- Structure:
- Chemical Name:
- 3-[5-(1,5-Dioxo-5-(p-fluophenylpentyl]-4R-phenyl-2-oxazolidinone
- CAS:
- 404874-93-7
- MF:
- C20H18FNO4
- Structure:
- Chemical Name:
- 5-[Bis(2-chloroethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid Methyl Ester
- CAS:
- 109882-25-9
- MF:
- C17H23Cl2N3O2
- Structure:
- Chemical Name:
- 3-Bromo-5-chloropyrazine-2-carbonitrile
- CAS:
- 440124-25-4
- MF:
- C5HBrClN3
- Structure:
- Chemical Name:
- 6-(5-Chloro-2-pyridyl)-6,7-dihydro-7-hydroxy-5H-pyrrolo[3,4-b]pyrazin-5-one
- CAS:
- 43200-81-3
- MF:
- C11H7ClN4O2
- Structure:
- Chemical Name:
- 2(1H)-Quinolinone,7-(4-chlorobutoxy)-
- CAS:
- 913613-82-8
- MF:
- C13H14ClNO2
- Structure:
- Chemical Name:
- -Oxo-a-propylenanthic Acid Ethyl Ester
- CAS:
- 96610-56-9
- MF:
- C12H22O3
- Structure:
- Chemical Name:
- 5'-Deoxy-5-fluoro-N-[(2-methylbutoxy)carbonyl]cytidine
- CAS:
- 910129-15-6
- MF:
- C15H22FN3O6
- Structure:
- Chemical Name:
- methyl 2,4-bis{2-nitrophenyl}-6-methyl-1,2,3,4-tetrahydro-5-pyrimidinecarboxylate
- CAS:
- 108139-78-2
- MF:
- C19H18N4O6
- Structure:
- Chemical Name:
- Dehydrodeoxy Donepezil (Donepezil Impurity)
- CAS:
- 120013-45-8
- MF:
- C24H29NO2
- Structure:
- Chemical Name:
- Zolmitriptan
- CAS:
- 139264-24-7
- MF:
- C16H21N3O2
- Structure:
- Chemical Name:
- 2,3-Dimethylstyrene
- CAS:
- 40243-75-2
- MF:
- C10H12
- Structure:
- Chemical Name:
- 1,1'-Biphenyl-2-ylcarbamic acid
- CAS:
- 50443-60-2
- MF:
- C13H11NO2
- Structure:
- Chemical Name:
- 2α,3β,23-Trihydroxyolean-12-en-28-oic acid β-D-glucopyranosyl ester
- CAS:
- 62369-72-6
- MF:
- C36H58O10
- Structure:
- Chemical Name:
- 10-[3-(Dimethylamino)propyl]-10H-phenothiazine 5-oxide
- CAS:
- 146-21-4
- MF:
- C17H20N2OS
- Structure:
- Chemical Name:
- (6E,10E)-7,11,15-Trimethyl-3-methylene-1,6,10,14-hexadecatetrene
- CAS:
- 70901-63-2
- MF:
- C20H32
- Structure:
- Chemical Name:
- 4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose
- CAS:
- 68128-53-0
- MF:
- C19H33NO13
- Structure:
- Chemical Name:
- CLARITHROMYCIN OXIME
- CAS:
- 127253-06-9
- MF:
- C38H70N2O13
- Structure:
- Chemical Name:
- PYRIDINE,3,5-BIS(BROMOMETHYL)-
- CAS:
- 35991-75-4
- MF:
- C7H7Br2N
- Structure:
- Chemical Name:
- alpha-Hydroxy-alpha-phenylbenzeneacetic acid (3-endo)-8-azabicyclo[3.2.1]oct-3-yl ester hydrochloride
- CAS:
- 63516-30-3
- MF:
- C21H24ClNO3
- Structure:
- Chemical Name:
- N-(4-(METHYLAMINO)BENZOYL)-L-GLUTAMIC ACID
- CAS:
- 52980-68-4
- MF:
- C13H16N2O5
- Structure:
- Chemical Name:
- (2R)-N-(2,6-DIMETHYLPHENYL)-2-PIPERIDINECARBOXAMIDE
- CAS:
- 27262-43-7
- MF:
- C14H20N2O
- Structure:
- Chemical Name:
- ICARISIDE B5
- CAS:
- 114226-08-3
- MF:
- C19H32O8
- Structure:
- Chemical Name:
- Atorvastatin Lactam Impurity
- CAS:
- 906552-18-9
- MF:
- C33H35FN2O6
- Structure:
- Chemical Name:
- 1,3-Bis(9H-carbazol-4-yloxy)-2-propanol (Carvedilol Impurity)
- CAS:
- 1276477-91-8
- MF:
- C27H22N2O3
- Structure:
- Chemical Name:
- Atorvastatin Lactone Diepoxide
- CAS:
- 1046118-40-4
- MF:
- C33H33FN2O6
- Structure:
- Chemical Name:
- 2-Carboxybenzoyl Amlodipine
- CAS:
- 318465-73-5
- MF:
- C28H29ClN2O8
- Structure:
- Chemical Name:
- rac-trans-4-Desfluoro-4-methoxy Paroxetine Hydrochloride
- CAS:
- 127017-74-7
- MF:
- C20H24ClNO4
- Structure:
- Chemical Name:
- Des(isopropoxyethyl) Bisoprolol
- CAS:
- 62572-93-4
- MF:
- C13H21NO3
- Structure:
- Chemical Name:
- Desmethoxy Fluvoxamine
- CAS:
- 1217216-82-4
- MF:
- C14H19F3N2O
- Structure:
- Chemical Name:
- 4'-Deoxy Vincristine
- CAS:
- 68135-16-0
- MF:
- C46H56N4O9
- Structure:
- Chemical Name:
- Demethyl Chlorpromazine Hydrochloride
- CAS:
- 3953-65-9
- MF:
- C16H18Cl2N2S
- Structure:
- Chemical Name:
- 6-Hydroxy-6-defluoro Ciprofloxacin
- CAS:
- 226903-07-7
- MF:
- C17H19N3O4
- Structure:
- Chemical Name:
- N-(2-Succinyl) Fluvoxamine
- CAS:
- 259526-43-7
- MF:
- C19H25F3N2O6
- Structure:
- Chemical Name:
- Methylene-Bis Paroxetine Dihydrochloride
- CAS:
- 606968-05-2
- MF:
- C39H40F2N2O6
- Structure:
- Chemical Name:
- Nicorandil N-Oxide
- CAS:
- 107833-98-7
- MF:
- C8H9N3O5
- Structure:
- Chemical Name:
- 2-Phenyl-1-[4-(trifluoromethyl)phenyl]ethane 2-(Aminoethyl)oxime (Fluvoxamine Impurity)
- CAS:
- 1217241-15-0
- MF:
- C17H17F3N2O
- Structure:
- Chemical Name:
- cis-Montelukast
- CAS:
- 774538-96-4
- MF:
- C35H36ClNO3S
- Structure:
- Chemical Name:
- (S)-(-)-Tolvaptan
- CAS:
- 331947-44-5
- MF:
- C26H25ClN2O3
- Structure:
- Chemical Name:
- N-tert-Butoxycarbonyl Mirabegron
- CAS:
- 1329485-55-3
- MF:
- C26H32N4O4S
- Structure:
- Chemical Name:
- (1R,3S)-1-(1,3-Benzodioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester
- CAS:
- 171596-44-4
- MF:
- C20H18N2O4
- Structure:
- Chemical Name:
- Amlodipine-d4
- CAS:
- 1185246-14-3
- MF:
- C20H25ClN2O5
- Structure:
- Chemical Name:
- SiMvastatin 4'-Methyl Ether
- CAS:
- 864357-88-0
- MF:
- C26H40O5
- Structure:
- Chemical Name:
- (2S,3S,5S)-5-(tert-Butoxycarbonylamino)-2-(N-5-thiazolylmethoxycarbonyl)amino-1,6-diphenyl-3-hydroxyhexane
- CAS:
- 162849-95-8
- MF:
- C28H35N3O5S
- Structure:
- Chemical Name:
- 4-DesMethoxy-4-broMo TriMethopriM
- CAS:
- 16285-82-8
- MF:
- C13H15BrN4O2
- Structure:
- Chemical Name:
- Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate
- CAS:
- 82398-34-3
- MF:
- C12H24N5O5Pt2+
- Structure:
- Chemical Name:
- 3-(1-Naphthalenyloxy)propiophenone
- CAS:
- 41198-42-9
- MF:
- C19H16O2
- Structure:
- Chemical Name:
- 2-(1,3,2-Dioxaborinan-2-yl)benzamide
- CAS:
- 2377611-18-0
- MF:
- C10H12BNO3
- Structure:
- Chemical Name:
- Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate)
- CAS:
- 5740-62-5
- MF:
- C24H32O6