A pharmaceutical substance is such a biologically active substance, manufactured in strict accordance with current standards, which is intended for the production of a particular medicine. Production of pharmaceutical substances as mixtures of active components is possible. These substances are made synthetically. The work uses the most advanced biological, genetic, and cellular technologies.
Standards, Requirements and Rules
Today, manufacturers of pharmaceutical substances offer an equally wide range of both individual substances and those consisting of numerous components. It should be remembered: pharmaceutical substances are standardized, but deviations are possible. How large they can be is indicated in special articles, classifications, and specifications describing a particular substance. Such deviations are justified by the fact that pharmaceutical substances are made from animal, plant materials, that is, natural raw materials.
Suppliers of pharmaceutical substances, in addition to the direct substances themselves, also offer the market a fairly large selection of auxiliary components. They are used for the manufacture of a variety of dosage forms.
general information
What data is needed to comply with the order of importation of medicines and pharmaceutical substances into our country? Without what information is it impossible to register, produce, sell products?
Any substance must have a generic name accepted internationally. The manufacturer must indicate these data in the pharmacopoeial article attached to the substance. In addition, a name assigned in accordance with JUPAC will have to be reported. Data on the synthesis of pharmaceutical substances are expressed by indicating the structural, empirical formulas and molecular weight.
What is this about?
Mostly in the domestic market of pharmaceutical substances acid salts, organic bases are presented. The generic name for these substances include anion, cation. But the specification for a pharmaceutical substance called ester declares that the name must be written together. From here the difficult words a la “beclamethasondipropionate” are born.
Legal sale of pharmaceutical substances is possible only if an accurate and correct description has been drawn up for them. The color of the substance and the state in which the substance is present is prescribed in it. But the taste is not indicated by the rule. Some special categories of substances additionally require indicating hygroscopicity, odor. If the substance is presented in the form of a solid, it is additionally described, it is in the form of small crystals, crystals of normal size, or it is a powder without pronounced features of the constituent elements. The description of the crystal structure is considered one of the most significant parameters, since this structure determines the quality of the solid form of the drug.
We describe in detail!
As for the descriptions, the requirements for pharmaceutical substances often contain an obligation to mention the numerical range, that is, how large the particles that make up the mixture can be.A number of specialized substances are examined for what is the predominant form of the constituent crystals of the substance. If these tests are carried out, the data about them is taken out in the description in a separate section.
Pharmacological substances are examined for polymorphism. These experiments are required if polymorphism affects the activity of the components in the final drug. In addition, he can determine the technological qualities, pharmacological properties of the final substance.
Pharmaceutical Substances and Solvents
Solvents are used to detect how high the solubility of the substance. This indicator must be accurately identified so that the registration of pharmaceutical substances is successful, since this event requires a full description, including the main characteristics of the substance. Solvents used during testing on a substance should be from different parts of the polarity scale. This ensures sufficient coverage, therefore, the most complete picture of the component, which gives the largest amount of data provided for the registration of pharmaceutical substances.
Most often, the role of solvents is played by:
- water;
- alcohol 96%;
- hexane;
- acetone.
When checking the substances from which medicines will be made, it is categorically not recommended to use toxic and such substances that are easily flammable or boil. Examples of solvents not suitable for use with pharmaceutical substances: benzene, diethyl ether.
Do not fool!
In order to produce high-quality reliable medicines, you need to have good tested components, manufactured in strict accordance with current standards and requirements. Therefore, manufacturers of pharmaceutical substances conduct an authenticity test, the results of which are necessarily applied to the product to assure its reliability.
Authentication is done through chemical, physical methodologies. They resort to studying in the infrared spectrum, use absorption components, organize chromatography through gases, liquids. Qualitative reactions are carried out, not the least among which are specific ones.
In our country, a register of pharmaceutical substances is maintained, which indicates the main features of each substance on the list. It is important that the data from the registry and those shown by the substance in a real experiment.
Pharmaceutical Substances: Returning to Terminology
The fact that they are pharmaceutical substances, tell us the federal laws in force in our country. The drug market in Russia is regulated by the authorities quite clearly, which imposes certain restrictions on manufacturers. Those companies that want to work with pharmaceutical substances should know that, according to the law, they include only components that can be called medicinal, while the substance is the active part that forms the basis of the drug. The effectiveness of the final product depends on it, therefore control over the manufacture, testing, quality of the goods is so important.
In addition, active pharmaceutical substances, i.e., APS, are isolated. This category includes both independent substances and compounds of several components. A variety of medicines are also made from them. A key feature of APS is the conversion of this substance during the manufacturing process of the drug into the active component. APS show pharmacological activity. Their presence in the composition of the medication allows you to achieve various goals. Components are used in the means used in the process of diagnosing diseases, in the treatment, elimination of symptoms.Some APS are known as elements that are indispensable in creating preventive medicines, while others affect the structure and functions of the human body.
Registration is a delicate matter
In order for a pharmaceutical substance to be used in industry, it must first be registered, entered in the register mentioned above, and only after that use becomes legal and legal. The registry is maintained at the state level and contains all drugs that can be imported into the country, as well as components that can be used in industry and medicine. 61 Federal Laws are devoted to this issue, and specifically, 33, 45 articles.
In order for a pharmaceutical substance to be registered, it must be sent for examination. By law, the authority responsible for this issue has 61 days to conduct an expert study of the material. The manufacturer can independently contact the state authority or contact intermediaries.
For help!
In recent years, manufacturers of pharmaceutical substances are increasingly trying to work with intermediaries working with the Ministry of Health. It's not cheap, but still pretty profitable. It is not surprising, because the specialists of such companies know exactly the requirements prescribed in Russian laws, can correctly execute all the papers, as well as give advice to the manufacturer regarding the missing documentation or contentious issues.
As a rule, estimates of the examination time and approximate forecasts regarding financial investments in registration are made when the manufacturer provides information on the non-proprietary name, as well as dossiers on the substance, certificates, including those of international standard. Based on the data from these papers, a competent expert can assess the complexity of the upcoming registration and give useful recommendations regarding the simplification of the process and the preparation of additional official papers. It should be remembered that in practice, the registration of a substance can drag on for six months or even longer.
We work with a reliable partner
In today's market there are quite a lot of companies working with FS and AFS. When choosing a manufacturer of pharmaceutical substances for cooperation, a company specializing in medicines should responsibly study the files of each potential counterparty. When evaluating various offers, it is important not only to compare price lists, but also to pay attention to additional aspects: for example, how does a manufacturer of substances pack their goods? Is it possible to purchase items packaged in small containers? This may seem like an insignificant question, but it is often the packaging of the right volumes that helps save money and time. This issue is especially important for manufacturing pharmacies, where procurement volumes are not as large as those of large drug manufacturing plants.
When choosing a potential partner, you need to make sure that all the positions offered by him have already been registered and entered in the register. In addition, a reliable supplier necessarily adds a copy of the quality certificate to its products, which allows the customer to be confident in the reliability and originality of the supplied product.
It should be clarified whether the supplier offers to additionally send to the buyer data on the entry of the substance into the register; if there are none, it makes sense to request them additionally in order to have a complete documentation base for the supplied substances. A copy of the certificate, registration certificate will not be superfluous.
Remember, all these documents will come in handy at the stage when the drug manufacturer begins to prepare a registration dossier. To simplify this process, a number of companies additionally offer samples of substances specifically for referral for examination.
Which are there?
What is meant by the term pharmaceutical substances is more or less clear.But what substances belong to this category? The choice on the domestic market is simply huge - it is not surprising, because even in small industrial pharmacies hundreds or even thousands of medicines are made, each of which has its own unique active substance, that is, an active substance.
One of the substances that are in rather high demand in the market of the medical industry is ASD (third fraction). The substance has a rather specific smell, it is a thick liquid of a rather dark color, the shade is brown. This substance is not soluble in water, 96% alcohol can be used as a solvent. Another widely used substance in industry is benzyl benzoate. This is a chemical raw material that has a rather faint odor, is oily to the touch, and either has no color or gives off a yellowish tint. However, the substance is supplied in the form of crystals - also without color or practically without it.
Well-known names
The two examples cited are names that are almost unfamiliar to ordinary people. But there are others pharmaceutical substances, which, although they are chemical raw materials, are known to a wide range of people for their health benefits. A typical example is birch tar, used in the medical industry as a chemical raw material. According to the standard, it is such a thick black liquid that has an unusual smell, and is somewhat oily to the touch. Tar in water does not dissolve, but it can be successfully mixed with chloroform.
Boric acid, which has been stored in the medicine cabinet of almost every family since the Soviet era, is no less famous for wide circles. The industry uses it as a raw material in the form of a powder consisting of very fine white or almost white crystals, which can be dissolved not only with 96 percent alcohol, but also with plain water, especially boiling water.
Surprisingly, oil is also used in the medical industry. A specially made and refined substance is called refined Naftalan oil and is used in the manufacture of a variety of medicines. It is quite thick and similar to syrup, almost insoluble in water and alcohol, but it can be successfully mixed with chloroform. Oil color is black, the smell is pretty specific.
What else happens?
The pharmaceutical substance formalin is quite actively used, not only known to specialists in the field of medicine, but also to a wide range of people thanks to the eponymous song of the Russian-speaking group Fleur. However, if the song gives the impression that the formalin is white, cloudy, similar to fog, then in practice this liquid is colorless and transparent. Its distinctive feature is a rather pungent smell. Such chemical raw materials can be mixed with alcohol, water. Mixes in any proportion.
Another actively used substance is gum turpentine, alcohol is used as a solvent, but water will not be effective, since turpentine practically does not dissolve in it. It is a colorless liquid, transparent, sometimes giving off to yellow. A distinctive feature is an unusual smell.
Features of the bureaucracy: paper secrets
If the young company has decided to work with pharmaceutical substances, it will have to go through Cerberus, the bureaucracy, which guards the entrance to the world of the medical business. We are talking about the design of a variety of official papers, as well as inclusion in the registers operating at the state level.
In order for the substance to be included in the register, you need to prepare documents, focusing on 61 Federal Laws. For this, the company draws up an application, pays the state fee and saves a document confirming the fact of payment, prepares regulatory documents, provides a certificate confirming that all the standards and norms established by laws are complied with at the factory. Such paper is issued by the state authority and legalized. It will also be necessary to provide officials with a schematic description of the production process of the substance entered into the register and prepare its detailed description, including all the features mentioned above.Finally, you must have a certificate confirming the results of the production analysis of samples of the substance.