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.
Click on the specific product, view the latest prices of the products, information, serving information
- Chemical Name:
- Prasugrel IMpurity 6
- Structure:
- Chemical Name:
- RebaMipide 2-Chloro IMpurity
- CAS:
- 90098-06-9
- MF:
- C19H15ClN2O4
- Chemical Name:
- Ribavirin IMp. F (EP)
- Chemical Name:
- RocuroniuM BroMide IMpurity 17
- Structure:
- Chemical Name:
- SalMeterol IMpurity D
- MF:
- C25H37NO4
- Chemical Name:
- SulbactaM IMpurity A
- Structure:
- Chemical Name:
- Tigecycline Metabolite M6 (9-AniMoMinocycline)
- CAS:
- 149934-19-0
- MF:
- C23H28N4O7
- Structure:
- Chemical Name:
- VerapaMil IMpurity G
- MF:
- C27H38N2O4
- Structure:
- Chemical Name:
- EthanediaMide iMpurity D
- CAS:
- 480452-36-6
- MF:
- C21H30ClN5O5
- Structure:
- Chemical Name:
- N-(4-(2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine-6-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide
- CAS:
- 168626-93-5
- MF:
- C32H25N3O3
- Structure:
- Chemical Name:
- 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide
- MF:
- C24H22ClN5O3
- Structure:
- Chemical Name:
- Methyl (4-Methylpiperidin-3-yl)carbaMate
- CAS:
- 1204176-45-3
- MF:
- C8H16N2O2
- Structure:
- Chemical Name:
- (R)-3-(4-(5-broMo-2-chlorobenzyl)phenoxy)tetrahydrofuran
- CAS:
- 915095-90-8
- MF:
- C17H16BrClO2
- Structure:
- Chemical Name:
- (2S,3R,4S,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-tetrahydro-6-(hydroxyMethyl)-2-Methoxy-2H-pyran-3,4,5-triol
- CAS:
- 1358581-37-9
- MF:
- C25H27FO6S
- Structure:
- Chemical Name:
- Levocarnitine iMpurity
- CAS:
- 6490-20-6
- MF:
- C7H17ClN2O2
- Structure:
- Chemical Name:
- 3-Hydroxy-4-Methyl-2(5H)-thiophenone
- CAS:
- 34876-35-2
- MF:
- C5H6O2S
- Structure:
- Chemical Name:
- (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-diMethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl Ester (2Z)-2-Methyl-2-butenoic Acid
- CAS:
- 1048973-04-1
- MF:
- C24H34O5
- Structure:
- Chemical Name:
- (6α)-17,21-Dihydroxy-6-Methylpregna-1,4,9(11)-triene-3,20-dione
- CAS:
- 93269-35-3
- MF:
- C22H28O4
- Structure:
- Chemical Name:
- 1(2H)-Naphthalenone, 4-hydroxy-3-methyl-2-[(2E,6E,10E)-3,7,11,15-tetramethyl-2,6,10,14-hexadecatetraen-1-ylidene]-
- CAS:
- 693781-59-8
- MF:
- C31H40O2
- Chemical Name:
- Bisoprolol Impurity 50
- Chemical Name:
- Alvatrombopag Impurity 84
- Chemical Name:
- Avatrombopag Impurity 60
- Structure:
- Chemical Name:
- 2-Amino-4-(3-chlorothien-2-yl)-1,3-thiazole
- CAS:
- 339114-12-4
- MF:
- C7H5ClN2S2
- Chemical Name:
- Capecitabine Related Compound B
- Structure:
- Chemical Name:
- D-erythro-3,4-Dihydroxyphenylserine
- CAS:
- 51829-98-2
- MF:
- C9H11NO5
- Structure:
- Chemical Name:
- aztreonam
- CAS:
- 80951-91-3
- MF:
- C13H17N5O8S2
- Structure:
- Chemical Name:
- 5H-[1]Benzopyrano[2,3-b]pyridine,7-ethyl-(9CI)
- CAS:
- 639857-68-4
- MF:
- C14H13NO
- Structure:
- Chemical Name:
- [1,1-Biphenyl]-2,2,4,4,5,5-hexol(9CI)
- CAS:
- 76625-61-1
- MF:
- C12H10O6
- Chemical Name:
- Esmolol Impurity 45
- Chemical Name:
- Oprinone Impurity 6
- Structure:
- Chemical Name:
- lamivudine sulfoxide
- CAS:
- 160552-55-6
- MF:
- C8H11N3O4S
- Structure:
- Chemical Name:
- SRI 62320
- CAS:
- 94061-80-0
- MF:
- C24H25FNNaO4
- Structure:
- Chemical Name:
- Vitamin B12 e-Monocarboxylic Acid
- CAS:
- 26264-28-8
- MF:
- C63H87CoN13O15P
- Structure:
- Chemical Name:
- caffeidine
- CAS:
- 20041-90-1
- MF:
- C7H12N4O
- Chemical Name:
- metreleptin
- CAS:
- 186018-45-1
- Structure:
- Chemical Name:
- 3,5-DIIODO-4'-(4-HYDROXYPHENOXY)BENZOIC ACID
- CAS:
- 2055-97-2
- MF:
- C13H6I4O4
- Structure:
- Chemical Name:
- Sotalol EP Impurity A
- CAS:
- 16974-42-8
- MF:
- C12H20N2O2S
- Structure:
- Chemical Name:
- digoxigenin-mono(digitoxoside)
- CAS:
- 5352-63-6
- MF:
- C29H44O8
- Structure:
- Chemical Name:
- W 36017
- CAS:
- 21236-54-4
- MF:
- C12H18N2O
- Structure:
- Chemical Name:
- ONO EI-601
- CAS:
- 155023-59-9
- MF:
- C15H14N2O6S
- Structure:
- Chemical Name:
- norchlorpromazine
- CAS:
- 1225-64-5
- MF:
- C16H17ClN2S
- Structure:
- Chemical Name:
- ETHYLISOPROPYLNITROSAMINE
- CAS:
- 16339-04-1
- MF:
- C5H12N2O
- Structure:
- Chemical Name:
- 1,3,5,7-Tetrmethyl-adamantane
- CAS:
- 1687-36-1
- MF:
- C14H24
- Structure:
- Chemical Name:
- 4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one
- CAS:
- 34523-34-7
- MF:
- C8H9NO2
- Structure:
- Chemical Name:
- Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate
- CAS:
- 121659-86-7
- MF:
- C20H16FNO2
- Structure:
- Chemical Name:
- Silodosin
- CAS:
- 160970-64-9
- MF:
- C25H32F3N3O4
- Structure:
- Chemical Name:
- (3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE
- CAS:
- 76646-91-8
- MF:
- C8H9Br2NO5S
- Structure:
- Chemical Name:
- (S)-Citalopram N-Oxide
- CAS:
- 917482-45-2
- MF:
- C20H21FN2O2
- Structure:
- Chemical Name:
- 7-Epi-docetaxel (Docetaxel Impurity C)
- CAS:
- 153381-68-1
- MF:
- C43H53NO14
- Structure:
- Chemical Name:
- Amido Methyl Meloxicam (Meloxicam Impurity)
- CAS:
- 892395-41-4
- MF:
- C15H15N3O4S2
- Structure:
- Chemical Name:
- DESETHYLENE CIPROFLOXACIN
- CAS:
- 103222-12-4
- MF:
- C15H16FN3O3
- Structure:
- Chemical Name:
- 2-aminobutanenitrile
- CAS:
- 40651-89-6
- MF:
- C4H8N2
- Structure:
- Chemical Name:
- [N(Z)]-N-(3,5-DiMethyl-2(3H)-thiazolylidene)-4-hydroxy-2-Methyl-2H-1,2-benzothiazine-3-carboxaMide 1,1-Dioxide
- CAS:
- 1262333-25-4
- MF:
- C15H15N3O4S2
- Structure:
- Chemical Name:
- Quetiapine Impurity E
- CAS:
- 1371638-05-9
- MF:
- C40H44N6O2S2
- Structure:
- Chemical Name:
- 3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate
- CAS:
- 57073-55-9
- MF:
- C17H28N4O7S
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2402776-84-3
- MF:
- C23H27N9O4S2
- Structure:
- Chemical Name:
- Cyclopentanecarboxylic acid, 3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminocarbonyl)amino]-2-hydroxy-, (1S,2S,3R,4R)-
- CAS:
- 2597901-48-7
- MF:
- C15H27N3O5
- Structure:
- Chemical Name:
- 3-Isoquinolinecarboxylic acid, 7-(4-chlorophenoxy)-4-hydroxy-, methyl ester
- CAS:
- 2711953-58-9
- MF:
- C17H12ClNO4
- Chemical Name:
- (2-(2-((tert-butoxycarbonyl)(methyl)amino)-N-methylacetamido)pyridin-3-yl)methyl N-(tert-butoxycarbonyl)-N-methylglycinate
- Structure:
- Chemical Name:
- Benzoic acid, 3-(aminosulfonyl)-2,4-dichloro-
- CAS:
- 1870323-25-3
- MF:
- C7H5Cl2NO4S
- Structure:
- Chemical Name:
- Benzeneacetamide, N,α,α-trimethyl-N-[6-(4-methyl-1,4-dioxido-1-piperazinyl)-4-(2-methylphenyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)-
- CAS:
- 1431216-61-3
- MF:
- C30H32F6N4O3
- Structure:
- Chemical Name:
- 1,3-Dioxane-4-acetic acid, 6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-, sodium salt (1:1), (4R,6R)-
- CAS:
- 862260-38-6
- MF:
- C36H40FN2NaO5
- Chemical Name:
- Avatrombopag Impurity 54
- Chemical Name:
- Atorvastatin Impurity 45 (Sodium Salt)
- Chemical Name:
- Tafluprost Impurity 15
- Chemical Name:
- Rosuvastatin Impurity 159 （Sodium salt)
- Chemical Name:
- Rosuvastatin Impurity 140
- Chemical Name:
- Rosuvastatin Impurity 130
- Chemical Name:
- Terlipressin Impurity 1 (des-Gly1)
- Chemical Name:
- Brivaracetam Impurity 66
- Structure:
- Chemical Name:
- 2-Acetoxymethyl1-3-Methyl-4-
- CAS:
- 112525-75-4
- MF:
- C11H12F3NO3
- Chemical Name:
- N-(7-chloro-4-((3-chloro-4-fluorophenyl)amino)quinazolin-6-yl)-4-(dimethylamino)butanamide
- Chemical Name:
- Ertapenem Impurity D(USP)
- Structure:
- Chemical Name:
- 3-(N-Benzyl-N-methylamino)propiophenone hydrochloride
- CAS:
- 5409-62-1
- MF:
- C17H20ClNO
- Structure:
- Chemical Name:
- 2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)-
- CAS:
- 869884-24-2
- MF:
- C23H26N2O3
- Chemical Name:
- Azilsartan Medoxomil Potassium impurity209
- Chemical Name:
- Nelarabine impurity 01
- Structure:
- Chemical Name:
- Pyridine, 2-(diethylboryl)- (9CI)
- CAS:
- 385804-67-1
- MF:
- C9H14BN
- Structure:
- Chemical Name:
- Cyclopropanamine, 2-(3-fluorophenyl)-, (1R,2S)- (9CI)
- CAS:
- 220353-83-3
- MF:
- C9H10FN
- Chemical Name:
- Milnacipran Impurity 26
- Chemical Name:
- Olodaterol Impurity 15
- Chemical Name:
- Dobutamine Impurity 15
- Chemical Name:
- Dobutamine Impurity 15
- Chemical Name:
- Dobutamine Impurity 15
- Structure:
- Chemical Name:
- 2,3'-Bipyridine, 5-chloro-6'-methyl-3-[4-(methylthio)phenyl]-, hydrochloride (1:1)
- CAS:
- 1447814-82-5
- MF:
- C18H16Cl2N2S
- Chemical Name:
- Pitavastatin Impurity 104
- Chemical Name:
- Tegoprazan Impurity 8
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2706536-33-4
- MF:
- C27H34N2O2
- Chemical Name:
- Olodaterol Impurity 32
- Structure:
- Chemical Name:
- (R)-Lercanidipine Hydrochloride
- CAS:
- 187731-34-6
- MF:
- C36H42ClN3O6
- Structure:
- Chemical Name:
- 2-Oxo Clopidogrel Hydrochloride (Mixture of diastereomers)
- CAS:
- 109904-27-0
- MF:
- C16H16ClNO3S
- Structure:
- Chemical Name:
- 5-Hydroxy-6-methoxy-1-indanone
- CAS:
- 127399-78-4
- MF:
- C10H10O3
- Structure:
- Chemical Name:
- Desfluoro Citalopram Oxalate
- CAS:
- 1093072-86-6
- MF:
- C22H24N2O5
- Structure:
- Chemical Name:
- Didesmethyl Zolmitriptan
- CAS:
- 139264-15-6
- MF:
- C14H17N3O2
- Structure:
- Chemical Name:
- Gabapentin Related Compound E
- CAS:
- 67950-95-2
- MF:
- C9H14O4
- Structure:
- Chemical Name:
- Hydroxy Bosentan
- CAS:
- 253688-60-7
- MF:
- C27H29N5O7S
- Structure:
- Chemical Name:
- Lisinopril S,S,S-Diketopiperazine
- CAS:
- 328385-86-0
- MF:
- C21H29N3O4
- Structure:
- Chemical Name:
- rac 4-Desmethoxy-4-nitro Omeprazole
- CAS:
- 317807-10-6
- MF:
- C16H16N4O4S
- Structure:
- Chemical Name:
- trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol
- CAS:
- 201855-60-9
- MF:
- C19H22FNO
- Structure:
- Chemical Name:
- ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE
- CAS:
- 70458-94-5
- MF:
- C14H13ClFNO3